Statistical Science Director -Late Oncology

Location: Macclesfield (UK)

Competitive salary and benefits

Open to part-time workers, minimum 0.8FTE

Play a critical role in making our pipeline accessible to patients.

We are open to discussing working part-time (min 0.8FTE)

Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact all phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.

We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you'll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.

Main duties and responsibilities

In this role you will be responsible in leading the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team.

You will provide leadership to statistical staff on the indications/projects so that all work is carried out with regards to AZ standards and external regulations; through partnership with experts, developing design options and providing high quality decision support to enable the business to make informed decisions; quantifying the benefit, risk, value and uncertainty of the emerging product profile.

You will be holding CRO/Partners accountable for the high quality standards of their deliverables. You will represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications.

You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration. You will mentor/coach and support the education and training of Statistics staff in the technical arena.

Requirements

Essential

• MSc or PhD degree in Statistics, Biostatistics, or related quantitative fields, or equivalent course work/ technical experience
• Understanding of regulations/developments in the area of Clinical Development and Biostatistics
• Appropriate experience as a statistician for the relevant position level with clinical trials, pharmaceutical development, regulated research, and/or related areas of statistical applications
• A collaborative mindset
• A general dedication to and ability to apply expertise to problem solving
• Experience with relevant statistical software
• Ability to apply statistical techniques in the analysis of data from clinical studies or other significant are

Why AstraZeneca?

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next?

• Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIhttps://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
• Please our dedicated Biometrics page https://careers.astrazeneca.com/biometrics

Date role opened: 11th March 2024

Date role closed: 4th April 2024

The Role:

The Senior Director, CMC Regulatory Affairs will be responsible for managing a team of experts responsible for regulatory CMC activities through all stages of the lifecycle for product in their portfolio. The team will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities.  The Senior Director will be required to oversee the activities of the team, including review and approval of CMC and Quality related agency correspondence and regulatory applications for all the products in their portfolio.  The individual will be expected to actively participate in cross-functional governance teams for topics relevant for products in their portfolio.  The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients.  Effective communication skills will be critical to overall success.  The individual will also be responsible for mentoring and development of members of their team. The Senior Director will be based at the Norwood or Cambridge, MA site.

Here’s What You’ll Do:

• Lead a team to develop/implement effective CMC regulatory strategies for submissions
  (e.g. IND/CTA/BLA/MAA) and identify regulatory risks

• Provide expertise for regulatory CMC aspects of product development projects

• Review documents for submission-readiness, to ensure that all submissions conform to health authority guidelines and meet the need of the company

• Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions at the expert level

• Develop regulatory processes and procedures to support CMC components of regulatory submissions

• Support the creation and maintenance of CMC submission templates

• Provides CMC regulatory expertise to manufacturing and quality teams; evaluates CMC change controls

• Provides interpretation of domestic and international regulatory guidance documents, regulations and directives – advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs.  Be a site expert.

• Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfully

Here’s What You’ll Bring to the Table:

Minimum Qualifications

• MS/PhD degree in a scientific/engineering discipline

• 10+ years of experience in the pharmaceutical/biotech industry

• 8+ years of experience in Regulatory CMC, including DMF/ASMF submissions

• Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions

• Strong knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance

• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones

• Prior management experience required

• Exceptional written and oral communication

Preferred Qualifications

• MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable

• 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus

• 8+ years of experience in Biologics focused Regulatory CMC

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

#LI-LG1

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Statistical Science Associate Director (Principal level) - Late Oncology

Location: Macclesfield, UK

Competitive salary and benefits

We are open to discussing working part-time (min 0.8FTE)

Do you have expertise in, and passion for, Biostatistics? Would you like to apply your skills to impact the early phases of drug development and regulatory interactions, in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious disease. But we're more than one of the world's leading pharmaceutical companies.

Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. It's our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Fusing cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we are aiming to deliver 6 new molecular entities by 2025.

We work on some of the most complex and interesting challenges. A fast-paced and agile team, we are empowered and trusted to innovate and experiment. With access to our extensive capabilities and comprehensive pipeline, you'll be involved in countless submissions and a wide range of engaging projects along the complete drug development process.

What you will do:

You will be expected to:

• Take a leadership role and drive statistical thinking in cross-functional team projects, within an international environment
• Contribute to strategic planning and quantitative decision making in early clinical development programmes
• Lead the delivery and oversight on drug project(s) and/or studies to time, quality and standards, including partnering with CROs and with Programming
• Participate in applying, adapting and/or developing statistical methodology
• Contribute to development of new procedures and standards to increase quality, efficiency, and effectiveness
  

Depending on your experience, the role may also include:

• Interactions to influence key stakeholders and governance
• Acting as a technical expert in interactions with external providers and collaborators
• Mentoring and coaching junior staff and supporting them with education and training in statistics
• Working with regulatory agencies, e.g. attending meetings, answering questions

We offer the chance to influence drug development and the opportunity to gain experience across a range of challenging and exciting projects.

Essential in the role:

• MSc/PhD in Statistics or Mathematics (containing a substantial statistical component) with experience in pharma/healthcare or other relevant area
• Knowledge of the technical and regulatory requirements related to the role
• Leadership capabilities to be able to lead and direct project work
• Experience of data analysis and interpretation in a relevant area
• Strong knowledge of programming in R and/or SAS
• Excellent written and spoken English. Excellent communication skills (including communicating with non-statisticians) and ability to build strong relationships
• Excellent collaboration skills required - the energy to work across global & functional boundaries, both internally and externally
• Ability to apply statistical expertise to complex problems, problem solving and quality focus

Desirable in the role, dependent on experience:

• Experience of programme and study design
• Experience in the relevant therapeutic area
• Experience of regulatory interactions

Why AstraZeneca?

At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next?

• Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours.

Where can I find out more?

• Our Social Media, Follow AstraZeneca on LinkedIhttps://www.linkedin.com/company/1603/
• Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/
• Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en
• Our dedicated Biometrics page https://careers.astrazeneca.com/biometrics

Date role opened: 11th March 2024

Date role closed: 4th April 2024

Key Responsibilities:

• The design verification engineer is expected to check, test, and gate the product design for both performance and reliability.
• Draft a test plan to cover each feature in product spec, certification requirement, and customer application.
• Support on DFMEA documentation draft and maintenance.
• Test products' electrical & mechanical performance and reliability with lab equipment such as multi-meter, integrating sphere, oscilloscope, and environmental chamber.
• Testing equipment management & maintenance.
• Follow up on the quality issues found and verify the effectiveness of corrective action.
• Give quality input during the early design stage to avoid potential quality issues.
• Update & deliver the test reports to the project lead and define the quality level of R&D stages.
• Work with QA to ensure the design quality can be delivered to the next phase.

Requirements:

• Bachelor’s in Electronic Engineering, computer science, or relevant majors.
• At least 8 years of design, testing, or quality experience.
• Experience in power electronics product testing and understanding of electronic product schematics is required.
• Operation experience with basic electronic equipment like oscilloscope, multimeter, power supply, and load are required.
• Knowledge or experience in electronic design, design quality, MCU, FW testing & appliances is preferred.
• Able to travel overseas.
• Familiar with UL standards will be an added advantage.
• Proficient in English and chinese to liase with HQ counterpart

Key Responsibilities:

• The design verification engineer is expected to check, test, and gate the product design for both performance and reliability.
• Draft a test plan to cover each feature in product spec, certification requirement, and customer application.
• Support on DFMEA documentation draft and maintenance.
• Test products' electrical & mechanical performance and reliability with lab equipment such as multi-meter, integrating sphere, oscilloscope, and environmental chamber.
• Testing equipment management & maintenance.
• Follow up on the quality issues found and verify the effectiveness of corrective action.
• Give quality input during the early design stage to avoid potential quality issues.
• Update & deliver the test reports to the project lead and define the quality level of R&D stages.
• Work with QA to ensure the design quality can be delivered to the next phase.

Requirements:

• Bachelor’s in Electronic Engineering, computer science, or relevant majors.
• At least 5 years of design, testing, or quality experience.
• Experience in power electronics product testing and understanding of electronic product schematics is required.
• Operation experience with basic electronic equipment like oscilloscope, multimeter, power supply, and load are required.
• Knowledge or experience in electronic design, design quality, MCU, FW testing & appliances is preferred.
• Able to travel overseas.
• Familiar with UL standards will be an added advantage.
• Proficient in English and chinese to liase with HQ counterparts.

Key Responsibilities:

• The design verification engineer is expected to check, test, and gate the product design for both performance and reliability.
• Draft a test plan to cover each feature in product spec, certification requirement, and customer application.
• Support on DFMEA documentation draft and maintenance.
• Test products' electrical & mechanical performance and reliability with lab equipment such as multi-meter, integrating sphere, oscilloscope, and environmental chamber.
• Testing equipment management & maintenance.
• Follow up on the quality issues found and verify the effectiveness of corrective action.
• Give quality input during the early design stage to avoid potential quality issues.
• Update & deliver the test reports to the project lead and define the quality level of R&D stages.
• Work with QA to ensure the design quality can be delivered to the next phase.

Requirements:

• Bachelor’s in Electronic Engineering, computer science, or relevant majors.
• At least 3 years of design, testing, or quality experience.
• Experience in power electronics product testing and understanding of electronic product schematics is required.
• Operation experience with basic electronic equipment like oscilloscope, multimeter, power supply, and load are required.
• Knowledge or experience in electronic design, design quality, MCU, FW testing & appliances is preferred.
• Able to travel overseas.
• Familiar with UL standards will be an added advantage.
• Proficient in English and chinese to liase with HQ counterparts.

Job Description Summary

Do you thrive in environments where strategic thinking meets hands-on problem-solving? If so, then this is your chance to make a transformative impact at BD.
As Director, R&D, Product Development, you will become the architect of our future, shaping the materials science function and capability across diverse business platforms within our $4B+ business unit (BU). You will lead a dynamic team of experts, advancing the BU’s innovation agenda and shaping the future of a broad, global portfolio of drug, device, combination products, where materials science innovation is critical to sustained market leadership.
Beyond a leadership opportunity, it's a chance to be a catalyst for change. You will be entrusted with optimizing the existing portfolio, leveraging your deep technical and product development expertise to identify and implement improvements that enhance performance, sustainability, and cost-effectiveness. Simultaneously, you will be a visionary leader, empowered to build a strong, collaborative R&D team, fostering a culture of continuous learning, and pushing the boundaries of what's possible.
You will be a strategic thought partner, collaborating across business platforms, the corporation, and the external ecosystem, to infuse materials science advances throughout our operations and portfolio.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

BD Medical is an ~$9B segment consisting of three Business Units (Medication Delivery Solutions, Medication Management Solutions and Pharmaceutical Systems) arising from the merger of BD, CareFusion and CR Bard. The Medication Delivery Solutions (MDS) business is a ~$4B business for the BD Medical Segment and is made up of 4 fully integrated, cross-functional business platforms (i.e., Peripheral Intravascular Catheters, Advanced Access Devices, Infusion Preparation & Delivery, Catheter Care & Injection Systems).

Role Overview:

Do you thrive in environments where strategic thinking meets hands-on problem-solving? If so, then this is your chance to make a transformative impact at BD.

As Director, R&D, Product Development, you will become the architect of our future, shaping the materials science function and capability across diverse business platforms within our $4B+ business unit (BU). You will lead a dynamic team of experts, advancing the BU’s innovation agenda and shaping the future of a broad, global portfolio of drug, device, combination products, where materials science innovation is critical to sustained market leadership.

Beyond a leadership opportunity, it's a chance to be a catalyst for change.  You will be entrusted with optimizing the existing portfolio, leveraging your deep technical and product development expertise to identify and implement improvements that enhance performance, sustainability, and cost-effectiveness. Simultaneously, you will be a visionary leader, empowered to build a strong, collaborative R&D team, fostering a culture of continuous learning, and pushing the boundaries of what's possible.

You will be a strategic thought partner, collaborating across business platforms, the corporation, and the external ecosystem, to infuse materials science advances throughout our operations and portfolio.

The position is based in Franklin Lakes, NJ.

Primary Responsibilities

Portfolio Leadership & Innovation:

• Set the material strategy for multiple businesses to ensure compliance to an ever-changing regulatory landscape and work with the businesses to convert the strategy to an implementable roadmap.
• In partnership with business platforms, lead the development and implementation of a comprehensive sustainability strategy and roadmap.
• Think strategically and partner with business platforms to develop a clear vision for the future of the portfolio, addressing business’ growth and profitability aspirations.
• Ensure timely and robust delivery of the product development portfolio, driving execution across functions and sites and ensuring effective and compliant commercialization of new products.
• Integrate sustainability principles into all stages of the product development process, from material selection to manufacturing and end-of-life considerations.
• Manage intellectual property portfolio related to the assigned portfolio.
• Stay informed about emerging technologies and market trends, anticipating future needs and driving innovation in the medical device materials landscape.

People & Organization Development:

• Build and lead a diverse, high-performing expert organization with expertise in diverse material areas such as materials science, chemistry, and engineering.
• Be the voice of the materials function across the organization.
• Cultivate a culture of innovation, collaboration, and continuous learning, fostering talent development and empowering team members to reach their full potential.
• Champion diversity, equity, and inclusion within the team and foster a collaborative and respectful work environment.
• Implement talent development programs and identify opportunities for team members to grow and advance their careers.

Collaboration & Relationship Building:

• Foster a collaborative environment, partner closely with cross-functional teams within BU platforms to ensure business continuity and successful commercialization of new solutions.
• Collaborate with sustainability experts within BD to ensure alignment with broader company goals and contribute to industry-wide sustainability initiatives.
• Build strong relationships with internal and external stakeholders, including academic institutions, research partners, and industry leaders.

Qualifications:

This role requires a seasoned leader with deep expertise in materials science, a passion for bringing differentiated and sustainable solutions to market and a strong commitment to people development and collaboration.

• PhD in Chemistry, Materials Science, or related field.
• 10+ years of experience (preferred) in R&D leadership with a proven track record of success in product development, in a regulated environment, preferably in medical devices.
• Demonstrated experience in leading and developing high-performing, geographically and culturally diverse teams.
• Strong communication, collaboration, and relationship building skills, with the ability to influence and build trust across various departments and organizations.
• Strategic thinking and problem-solving skills, with the ability to translate scientific concepts into practical applications.
• Passion for medical device innovation and a commitment to sustainability principles.
• Strong knowledge of intellectual property protection and experience in managing patent portfolios (preferred).
• Experience with regulatory requirements and processes relevant to medical devices (a plus).

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. 

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

How Will You Make an Impact?

​Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of over $40 billion.

Everything we do starts with our Mission: to enable our customers to make the world healthier, cleaner, and safer.

The nature of our business is to enable growth and innovation within the global scientific community and to help researchers, organizations, and companies tackle some of the world’s most pressing issues. We do that by providing ground breaking technologies and services that are the result of our significant investment in research and development.

We believe crafting a better tomorrow starts with the action we take today, and we continually strive toward improvement and excellence for the benefit of our customers, our colleagues, and the world.

What will you do?

• Use systems engineering approaches, we partner with the R&D/technical lead to guide the project team to research and develop life science systems to address sophisticated challenges and/or improve customers' workflow.
• We initiate and guide discussions with key partners to generate requirements
• We refine and manage requirements to ensure they are timely implemented at different stages
• We support the development team in feasibility studies and concept selection through concept testing activities
• We lead system integration activities to ensure a smooth and timely transition from design to operations
• We partner and support our regulatory affairs representative during product development to meet relevant ISO and FDA standards and guidelines
• We undertake and address vital tasks to achieve the product launch objectives

How will you get here?

Education / Experience

• Minimum bachelor’s degree in electrical/electronic or mechanical engineering field
• At least 5 years of R&D experience in either product design, medical device consumable development/manufacturing or systems engineering

Knowledge, Skills, Abilities

• Experience in the field of Gene/Cell Therapy or relating instrumentations and technologies e.g. electrophoresis, electroporation etc. will be an added advantage.
• Experience in development and manufacturing of consumables for sterile use
• Knowledge in medical or cell/gene therapy regulatory standards are useful.
• Hands on ability with acute analytical and trouble shooting skills are vital to succeed in the role.
• Proficient in communication and collaborators’ management
• Work well with team members from a diverse set of backgrounds and teams.
• Proficiencies in general Engineering, instrument/consumables manufacturing subject areas.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Company :

Allegheny Health Network

Job Description : 

GENERAL OVERVIEW:

This psychologist develops, implements, coordinates, and evaluates all aspects of the Behavior Medicine component of the program.

ESSENTIAL RESPONSIBILITIES:

• Precepts Residents with patients in the center, conducts hospital rounds with physician faculty and residents, gives presentations at conferences, reviews videotaped interviews, coordinates outside consultants for teaching purposes and does ongoing development of the curriculum in this area. (80%)
• Coordinates the Social Services connected with the Residency Program. (10%)
• Coordinates and facilitates the staffing (evaluation sessions) of the residents on a periodic basis. (10%)

QUALIFICATIONS:

Minimum

• Master's Degree as a clinical counselor, therapist, or social workers with counseling experience
• Teaching experience

Preferred

• PhD level psychologist with a combination of education, training and experience that equals to a minimum of 2 years professional activity in some aspect of behavioral science
• Teaching in primary care medical setting

Disclaimer: The job description has been designed to indicate the general nature and essential duties and responsibilities of work performed by employees within this job title. It may not contain a comprehensive inventory of all duties, responsibilities, and qualifications required of employees to do this job.

Compliance Requirement: This job adheres to the ethical and legal standards and behavioral expectations as set forth in the code of business conduct and company policies.

As a component of job responsibilities, employees may have access to covered information, cardholder data, or other confidential customer information that must be protected at all times.  In connection with this, all employees must comply with both the Health Insurance Portability Accountability Act of 1996 (HIPAA) as described in the Notice of Privacy Practices and Privacy Policies and Procedures as well as all data security guidelines established within the Company’s Handbook of Privacy Policies and Practices and Information Security Policy. 

Furthermore, it is every employee’s responsibility to comply with the company’s Code of Business Conduct. This includes but is not limited to adherence to applicable federal and state laws, rules, and regulations as well as company policies and training requirements.

Highmark Health and its affiliates prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, age, religion, sex, national origin, sexual orientation/gender identity or any other category protected by applicable federal, state or local law. Highmark Health and its affiliates take affirmative action to employ and advance in employment individuals without regard to race, color, age, religion, sex, national origin, sexual orientation/gender identity, protected veteran status or disability. 

EEO is The Law

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation/Gender Identity (https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf)

We endeavor to make this site accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact number below.

For accommodation requests, please contact HR Services Online at HRServices@highmarkhealth.org

California Consumer Privacy Act Employees, Contractors, and Applicants Notice

about the role

• Oversee day-to-day manufacturing operations
• Design strategy and set goals for growth
• Development and implementation of the long-term strategic plan
• Maintain budgets and optimize expenses
• Set policies,processes and procedure for the business
• Identify training development needs as a whole for the business
• Provide solutions to issues (e.g. profit decline, employee turnover, business loss to competitor)
• Provide performance report to board
• R&D new product development
• oversees new product transfers, qualifications and mass production

skills and experience required

• Master / Degree in Engineering or relevant qualification
• Minimum 15 years of working experience in R&D manufacturing environment (industrial automation)
• High volume manufacturing environment will be a plus
• PMP & Six sigma certified will be a plus
• Strong experience in cost saving / industry 4.0 transformation / digitalisation project
• Manage core team consists of R&D / product management / supply chain / HR / Manufacturing operations

If you are interested in the position , kindly send your CVs to yitwei.kwan(@)randstad.com.sg

Please include your availability, expected salary and reason for leaving current job

We regret that only shortlisted candidates will be contacted

EA: 94C3609 / Reg: R1325913

Job Scope:

• Responsible for 3D product design and its requirements
• Lead in Mechanical and Engineering Design for Process Development or Product Design or Engineering solutions
• Create proof of concepts
• Generate engineering drawing with proper GD&T and Tolerance Stack up
• Define test requirements needed for all the designed products
• Perform Patent search for possible design infringement
• Drive Projects with tight timeline
• Any other duties as and when assigned
• Take reasonable care of workplace health and safety; abide by all EHS policies and procedures; cooperate with Management and colleagues in EHS initiatives

Period:

• Permanent

Location:

• Joo Koon

Working Hours:

• Monday to Friday, 8.30am to 5.45pm

Salary:

• Up to $6000

Requirements:

• Bachelor Degree in Mechanical / Industrial
• 1-2 years of relevant experience
• Good exposure in Plastic Injection molded parts design
• Knowledge of product design, engineering plastics behavior, product certification
• Knowledge of CAE simulation will be an added advantage
• Competent in Engineering calculations
• Hands on 3D CAD & CAE experience
• Good problem solving skills with strong technical acumen

In lieu of physical interviews, we will be conducting virtual interview, i.e. Skype/WhatsApp/Facetime/Zoom

Interested applicants, kindly email your detailed resume (MS Word format is preferred):

tracy@successhrc.com.sg (Registration no: R1107390)

huiling@successhrc.com.sg (Registration no: R1111404)

Please ensure that applications sent through email are no bigger than 1Mb.

We thank all applicants for your interest but regret to inform that only shortlisted candidates would be notified.

Success Human Resource Centre Pte Ltd (EA License Number: 97C4832)

3 Shenton Way, #19-01 Shenton House, Singapore 068805

T: 6337 3183 | F: 6337 0329 | W: www.successhrc.com.sg

Responsibilities:

As part of our small and dynamic team you play a key role in the design and development of our Inspection and Metrology machines. In your role you will work hands-on on the mechanical integration, process optimization and automation of the machine. Your work will involve integration of the mechatronic, optical and SW building blocks and will hence work closely together with Mechanical design, Hardware, Optics and SW teams.

It is your job to analyse customer requirements, build up a deep understanding of the problem and translate these in automated solutions that you detail clearly in measurable design requirements. To verify the solutions, you will build and test high-speed mechatronic setups for spec validation and critical parameter analysis. Once these are confirmed, you will coordinate the design and implementation in the different teams to eventually integrate tested modules and building blocks in the machine and assess the impact of the integration on the overall machine performance.

You get the chance to confirm high speed Pick and Place handling capabilities at key customers on site and broaden your customer and application know how along the way.

Furthermore you seek the challenge of understanding, analyzing, (re-)defining, and implementing sophisticated material handling flows until the level of detailed micro-sequences.

You will often write PLC level test sequences for mockup validation and data collection. Once the system is validated, translate these sequences into SW requirements.

You consider the total system life cycle, the birth to death concept extends to maintenance, replacement and decommission.

Requirements:

• MS degree or BS degree with outstanding skill in electro-mechanical, electronics, software or mechanical engineering.
• 7+ years relevant experience in an automation oriented engineering role in a high-end equipment company, covering most of following technical domains: machine conceptual and mechanical design, setting up specifications, PLC controller hardware and software design, user interface, SW (describing, testing of flows), conversion, test protocols, debugging, characterization, lead improvement projects
• Strong analytical capabilities
• Programming skills are a plus (PLC controllers, C, C++ Python, VBA, …)
• Independent thinking, challenging existing ideas and approaches
• Hands-on, self-organized, taking initiative and ownership
• Occasional travel within Asia & Europe
• Proficient in English

Become a part of our caring community and help us put health first
 

The Associate Director, Actuarial provides actuarial support across a broad range of actuarial and business needs for specific product lines. The Associate Director, Actuarial requires a solid understanding of how organization capabilities interrelate across department(s).

The Associate Director, Actuarial may be responsible for any combination of valuation, pricing, analytics, forecasting, risk, compliance, and operations. Decisions are typically related to identifying and resolving complex technical and operational problems within department(s), and could lead multiple managers or highly specialized professional associates.

Use your skills to make an impact
 

Required Qualifications

• Bachelor Degree
• FSA or ASA plus relevant advanced degree, extensive work experience, and/or other relevant professional designations
• MAAA
• Demonstrated leadership capability, has led sizable staff before
• Experience in leading other human capital leaders
• Strong Communication Skills
• Experience in more than three functions (e.g., modeling, pricing, rate filing, reporting & analysis, reserving or trending) and more than one product.
• Must be passionate about contributing to an organization focused on continuously improving consumer experiences

Scheduled Weekly Hours

40

Pay Range

The compensation range below reflects a good faith estimate of starting base pay for full time (40 hours per week) employment at the time of posting. The pay range may be higher or lower based on geographic location and individual pay decisions will vary based on demonstrated job related skills, knowledge, experience, education, certifications, etc.

 

$153,500 - $211,300 per year

 

This job is eligible for a bonus incentive plan. This incentive opportunity is based upon company and/or individual performance.

Description of Benefits

Humana, Inc. and its affiliated subsidiaries (collectively, “Humana”) offers competitive benefits that support whole-person well-being. Associate benefits are designed to encourage personal wellness and smart healthcare decisions for you and your family while also knowing your life extends outside of work. Among our benefits, Humana provides medical, dental and vision benefits, 401(k) retirement savings plan, time off (including paid time off, company and personal holidays, volunteer time off, paid parental and caregiver leave), short-term and long-term disability, life insurance and many other opportunities.

About us
 

Humana Inc. (NYSE: HUM) is committed to putting health first – for our teammates, our customers and our company. Through our Humana insurance services and CenterWell healthcare services, we make it easier for the millions of people we serve to achieve their best health – delivering the care and service they need, when they need it. These efforts are leading to a better quality of life for people with Medicare, Medicaid, families, individuals, military service personnel, and communities at large.

Equal Opportunity Employer

It is the policy of  Humana not to discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or because he or she is a protected veteran. It is also the policy of  Humana to take affirmative action to employ and to advance in employment, all persons regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status, and to base all employment decisions only on valid job requirements. This policy shall apply to all employment actions, including but not limited to recruitment, hiring, upgrading, promotion, transfer, demotion, layoff, recall, termination, rates of pay or other forms of compensation and selection for training, including apprenticeship, at all levels of employment.

   

Cornell University Library stands at the center of intellectual life at the university, fostering connections and knowledge that help faculty, students, staff, and researchers from around the world excel in research, scholarship, and creative expression. It supports and enhances faculty and student productivity through its extensive collections, cutting-edge services and facilities, and a deep network of digital resources.

The Library seeks a forward-looking Director, Science and Agricultural Libraries. Reporting to the Associate University Librarian for Public Services, the Director provides vision, leadership and administration for the programs, collections, and services of Cornell University Library’s science libraries, including Albert R. Mann Library, the Mathematics Library, the Edna McConnell Clark Physical Sciences Library, and the Flower-Sprecher Veterinary Library. The Director manages staff supporting physical and life sciences, agriculture, and several applied fields in the social sciences; current direct reports include heads for collections, instruction, and outreach, and the lead for evidence synthesis. The Director builds and maintains awareness of programs and strategic directions for the sciences and agriculture at Cornell and works with other library directors to ensure that library services meet the needs of those communities.

The Science and Agricultural Libraries unit currently includes 16 full-time Research, Teaching, and Extension faculty librarians and 15 full-time staff members. In addition to providing services related to collections, instruction, and research, the libraries collaborate with other unit libraries and with the Digital Scholarship Services and Research Data and Open Scholarship units. The libraries also work in coordination with state, national and international networks and organizations such as Cornell Cooperative Extension, USDA (United States Department of Agriculture), USAIN (United States Agricultural Information Network), AgNIC (Agriculture Network Information Collaborative), the Biodiversity Heritage Library (BHL), and SUNY (State University of New York).

Required Qualifications: 

• Master’s Degree in Library and Information Science from an ALA-accredited program or related field or international equivalent.

• At least 6 years of professional librarian experience combined with at least 3 years of demonstrated evidence of leadership and management in an academic or research library setting, including supervising, developing, and coaching staff.

• Demonstrated ability to foster an environment of diversity, equity, inclusion, and belonging.

• Demonstrated ability to foster effective working relationships with University faculty, students, staff, and administrators.

• Record of scholarship, professional involvement, community engagement, and service.

• Excellent interpersonal and communication skills: ability to listen actively, speak and write clearly, and effectively present information and ideas to groups.

Preferred Qualifications:

• Academic background or library experience with a focus on sciences and/or agriculture.

• Experience managing research life-cycle services such as evidence synthesis, systematic reviews, research data management, or data curation.

• Experience preparing and managing grants.

• Demonstrated expertise in planning and budget management.

This position is located in Ithaca, New York. The selected candidate will work on the Ithaca campus at least 4 days per week, with potential for entering into a flexible work arrangement to allow remote work 1 day per week. The university reserves the right to modify, suspend, revoke or terminate the hybrid work arrangement at any time.

Relocation assistance may be provided.  

Visa sponsorship is not available for this position.

Benefits:  Our comprehensive benefits package includes 22 vacation days, 13 paid holidays, health insurance, life insurance, university retirement contributions, childcare and adoption assistance, and child tuition reimbursement. Funding is available to support professional development. More information regarding Cornell’s generous benefits for contract college employees can be found here. This appointment will be at the Associate Librarian or Librarian rank with an anticipated salary range of $86,000-$136,000, dependent on experience and qualifications.     

Background: Cornell University is an innovative Ivy League university and a great place to work. Its inclusive community of scholars, students, and staff imparts an uncommon sense of larger purpose and contributes creative ideas to further the University's mission of teaching, discovery, and engagement. In addition to the main campus in Ithaca, NY, Cornell's expansive global presence includes the medical college's campuses on the Upper East Side of Manhattan and Doha, Qatar, as well as the new Cornell Tech campus being built on Roosevelt Island in New York City. The Ithaca campus sits on 2,300 acres in the heart of the Finger Lakes region. Ithaca, located roughly halfway between Manhattan and Toronto, offers a wealth of arts, culture, and activity while maintaining an eclectic college-town feel. Outdoor enthusiasts can take advantage of the multitude of rolling hills, breathtaking gorges, hiking trails, and lakes offering countless outdoor activities. The city has been named one of the top 100 places to live, a top 10 recreation city, a best green place to live, and one of the "foodiest" towns in America.

One of the leading academic research libraries in the United States, Cornell University Library is a highly valued partner in teaching, research, and learning at the university. With an operating budget of approximately $65 million and a staff of more than 350 FTE, the Library supports 2,700 faculty, 22,000 students and 94 PhD fields. Its world class collections, expert librarians, responsive services in physical and virtual library spaces inspire and nourish scholarship and learning. Cornell University Press, the first University Press in the US, has a staff of approximately 40 FTE, reports directly to the University Librarian.

Diversity and Inclusion:  As a university founded to be a place where “…any person can find instruction in any study,” diversity and inclusion are at the core of our values and mission. We strive to be a welcoming, caring, healthy, and equitable community where students, faculty, and staff with different backgrounds, perspectives, abilities, and experiences can learn, innovate, and work in an environment of respect, and feel empowered to engage in any community conversation. As a member of the Cornell University community, it is important to recognize our shared responsibility to each other to cultivate a culture of inclusion for all.  Cornell Core values    

Our Vision: Empowering Cornell’s research and learning community with deep expertise, innovative services, and outstanding collections strengthened by strategic partnerships.  

Our Mission: Cornell University Library promotes a culture of broad inquiry and supports the University’s mission to discover, preserve, and disseminate knowledge and creative expression. It engages with the ongoing transformations of society to deliver world-class physical and digital content and services critical to research, education, and outreach, now and in the future. The Library acts globally, supporting Cornell’s land grant mission in New York State and beyond, and builds partnerships within and outside the university. It invests in its staff, collections, and physical and virtual libraries. And, it serves as a neutral and trusted party supporting information access and scholarly communication. 

How to Apply:  All candidates must apply online via the Cornell Careers site. For full consideration, please include the following with your application: 

1. A cover letter;

2. A Curriculum Vitae;

3. A statement supporting diverse communities which may be incorporated into the cover letter or presented as a separate statement. Candidates are invited to outline their experiences and approaches to working with diverse communities through their research, teaching and service. Guidelines for candidates are here. 

Applications will be reviewed on a rolling basis until a viable pool of applicants is identified; early submission is strongly encouraged. Although we prefer to receive your application as one, multi-page pdf document, we will accept multiple documents in other formats.

   

Familiarize yourself with Cornell's COVID-19 workplace guidance as well as the university's COVID-19 services and information.

  

University Job Title:

Librarian I

Job Family:

Research

Level:

006

Pay Rate Type:

Salary

Pay Range:

$86,000.00 - $136,000.00

Remote Option Availability:

Hybrid Remote

Company:

Contact Name:

Bonnie Bailey

Job Titles and Pay Ranges:

Non-Union Positions

Noted pay ranges reflect the potential pay opportunity for each job profile. The hiring rate of pay for the successful candidate will be determined considering the following criteria:

• Prior relevant work or industry experience

• Education level to the extent education is relevant to the position

• Unique applicable skills

• Academic Discipline (faculty pay ranges reflects 9-month annual salary)

To learn more about Cornell’s non-union staff job titles and pay ranges, see Career Navigator.

Union Positions

The hiring rate of pay for the successful candidate will be determined in accordance with the rates in the respective collective bargaining agreement. To learn more about Cornell’s union wages, see Union Pay Rates.

Current Employees:

If you currently work at Cornell University, please exit this website and log in to Workday using your Net ID and password. Select the Career icon on your Home dashboard to view jobs at Cornell.

Online Submission Guidelines:

Most positions at Cornell will require you to apply online and submit both a resume/CV and cover letter.  You can upload documents either by “dragging and dropping” them into the dropbox or by using the “upload” icon on the application page. For more detailed instructions on how to apply to a job at Cornell, visit How We Hire on the HR website.

Employment Assistance:

For general questions about the position or the application process, please contact the Recruiter listed in the job posting or email mycareer@cornell.edu.

If you require an accommodation for a disability in order to complete an employment application or to participate in the recruiting process, you are encouraged to contact Cornell University's Office of Institutional Equity and Title IX at voice (607) 255-2242, or email at equity@cornell.edu.

Applicants that do not have internet access are encouraged to visit your local library, or local Department of Labor. You may also request an appointment to use a dedicated workstation in the Office of Talent Attraction and Recruitment, at the Ithaca campus, by emailing mycareer@cornell.edu.

Notice to Applicants:

Please read the required Notice to Applicants statement by clicking here. This notice contains important information about applying for a position at Cornell as well as some of your rights and responsibilities as an applicant.

EEO Statement:

Diversity and Inclusion are a part of Cornell University’s heritage. We are a recognized employer and educator valuing AA/EEO, and we do not tolerate discrimination based on any protected characteristic, including race, ethnic or national origin, citizenship and immigration status, color, sex/gender, pregnancy or pregnancy-related conditions, age, creed, religion, actual or perceived disability (including persons associated with such a person), arrest and/or conviction record, military or veteran status, sexual orientation, gender expression and/or identity, an individual’s genetic information, domestic violence victim status, familial status, marital status, or any other characteristic protected by applicable federal, state, or local law. We also recognize a lawful preference in employment practices for Native Americans living on or near Indian reservations in accordance with applicable law. 

Cornell University embraces diversity and seeks candidates who will contribute to a climate that supports students, faculty, and staff to all identities and backgrounds. We encourage individuals from underrepresented and/or marginalized identities to apply.

2024-02-19

Main Responsibilities

Join our dynamic team at Makino Asia, where you'll be at the forefront of cutting-edge technology, driving innovation and excellence in the realm of CNC Milling Machines and Automation.

As a valued member of our Research & Development department, your responsibilities will include:

1. Developing New Products and introducing Innovative Designs for our existing Series Products.
2. Crafting Customized Machines to meet the unique needs of our diverse customers.
3. Nurturing collaboration across various company departments, including Sales, Marketing, Product Management, Production, Supply Chain, Customer Support, etc.
4. Mastering the art of designing rigid, high-accuracy structural parts, as well as lightweight components for rapid, high-acceleration applications, working hand-in-hand with our Simulation and Test Engineers.
5. Pioneering the development of mechatronic units, integrating pneumatic, hydraulic, servo-electric, and sensor components to create seamless machine systems.
6. Engaging in Concept Design, Structural Simulation, Detailing, Prototyping, Testing, Production, Customer Support, and Monitoring machine performance at our clients' sites.
7. Leveraging our dedicated R&D Lab for innovative prototyping.
8. Enjoying mentorship from seasoned senior engineers, guiding you on your career path to success.
9. Embracing a global perspective by collaborating with an extensive network of Makino R&Ds, Sales Regions, and Key Suppliers.
10. Follow the workplace safety and health system, safe work procedures or safety rules implemented at the workplace.

Job Requirements:

To excel in this role and contribute significantly to our Research & Development team, we seek candidates with the following qualifications:

1. Degree or Master’s Degree in mechanical engineering from a reputable university, demonstrating a solid academic foundation.
2. Proven track record of at least 3 years in mechanical design, preferably in a production environment, showcasing your expertise in developing cutting-edge solutions.
3. A genuine passion for product design, understanding its pivotal role in driving innovation and bringing forth revolutionary products.
4. Unleash your creativity to envision novel and inventive solutions that push the boundaries of what's possible.
5. Exceptional analytical skills to tackle complex challenges, delivering reliable and efficient problem-solving.
6. Proficiency in industry-standard design tools and software, allowing you to materialize your ideas with precision and finesse.
7. Strong teamwork and communication abilities, enabling effective collaboration across multiple departments.
8. An enthusiastic learner, always seeking opportunities to stay abreast of the latest trends and advancements in the field of mechanical engineering.

If you are passionate about cutting-edge technology, enjoy creative problem-solving, and thrive in a collaborative environment, this is the ideal opportunity for you to make your mark in the world of advanced manufacturing and automation. We eagerly await your application to join our progressive and innovative team at Makino Asia.

Come be a part of our extraordinary journey at Makino Asia and together, let's shape the future of manufacturing technology!