Total 54 Project Director job vacancies in Science / R&D / Research category in The United States of America

Job description:

- Assist the company in their annual Par dividend review, focusing on system implementation and project management.

1. Working with related parties for user request/UAT/deploying dividend changes to company’ core system and illustration tools.
2. Act as actuarial representative in the respective working group ensuring adherence to project timeline/plan.
3. Work closely with Par Fund management team in bonus-related investigations, and project documentations.

Job requirements:

- Min A level/Diploma

- Experience in actuarial field with knowledge in Participating products, related SG local regulations and hand-on experiences in system implementation for bonus revision exercise.
- Prioritization, project and timeline management skills.

To apply, please email your resume in MS Word format govt@recruitexpress.com.sg indicating in your CV the following information:

Expected Salary:
Notice Required:
Reason for Leaving:

Only shortlisted candidates will be notified.

Jackie Ng May Ying (R1104602)

Recruit Express Pte Ltd

EA No: 99C4599

Raffles Place Area - Telok Ayer/ Raffles MRT

9-6

Salary capped at $4200/= per month

Contract 3 Months, starting Early Apr 2024

Responsibilities
1. Working with related parties for user request/UAT/deploying dividend changes to company’ core system and illustration tools.
2. Act as actuarial representative in the respective working group ensuring adherence to project timeline/plan.
3. Work closely with Par Fund management team in bonus-related investigations, and project documentations.

How to Apply:
send your resume and indicate role(s) you want to apply to: jocelynchan@recruitexpress.com.sg or telegram @jocelynchan

Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1331820

Our client is a leading crytographic technology development firm in Singapore, providing design and development services to its partners and customers. We have the following vacancy for:

R&D ASIC Project Manager (Product Development)

Responsibilities:

• Manage ASIC project lifecycle, from requirements, design, technical architecture, implementation, testing, acceptance, training and documentation.
• Maintain close monitoring of project progress and report potential risks and challenges in a timely manner with proposed course of actions.
• Determine and manage resources from start to finish with attention to budgetary limitations.
• Build and maintain relationships with external stakeholders.
• Oversee and/or prepare incoming and outgoing project documentation.
• Technical leadership of project team.
• Perform HDL coding, synthesis, verification, timing closure, tapeout for project.

Requirements

• A Bachelors or Masters Degree in Electrical/Electronics Engineering, Computer Engineering, or relevant fields.
• Minimum 5 years engineering experience in HDL coding, implementation and ASIC tapeout.
• Minimum 3 years of experience in project management or team lead in product development.
• Able to multi-task and manage various project elements simultaneously.
• Strong team leader and individual contributor.
• Good spoken and written communication skills in English.
• Singaporean only.

Interested applicants, kindly send in a copy of your updated resume in WORD document to hr@searchstaffing.com.sg stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at 6749 4236.

EA Personnel Registration No: R1324700

SOFTWARE DIRECTOR (Control Software / R&D Director/ Technical/ Engineering/ Semiconductor Equipment Automation)

Our client is a leading organisation specialised in developing Semiconductor machines.

Responsibilities:

• Manage a team of Software Engineers in the design and development of real-time software and automation control systems of semiconductor equipment.
• Develop and implement software methodology, documentation/library system and tools to support software sustaining and new development projects.
• Define software architecture and procedures as standard best practices for all design, coding, testing and deployment activities.
• Spearhead the research, development and deployment of new-generation software engineering technologies.
• Extend technical support to various engineering functional groups in debugging and problem solving critical field issues

Requirements:

• Degree in Electrical & Electronics Engineering/Computer Studies or its equivalent
• More than 10 years in a managerial capacity overseeing software development and automation control in a related industry
• Experienced in programming on Windows (XP and above) environment.
• Highly versatile in C/C++, MFC, SQL and OOP.
• Good knowledge in developing multi-threaded control software, SEMI SECS/ GEM equipment connectivity standard and Software Development Life Cycle.
• Hardware experience in using Servo, Stepper Motion Controller, Analog Device and High Speed I/O.
• Strong analytical and problem-solving skills.
• Excellent team player

Interested candidates, please e-mail resume in Word document (indicating your current salary and expected salary) to:

Joey

Recruitment Manager

Right Recruit Pte. Ltd.

10 Anson Road, #33-03, International Plaza, Singapore 079903

EA Licence No: 23C1743 | EA Reg No: R1103523

www.rightrecruit.com.sg

Job Responsibilities:

- Working with related parties for user request / UAT / deploying dividend changes to core system and illustration tools

- Act as actuarial representative in the respective working group ensuring adherence to project timeline / plan

- Work closely with management team in bonus-related investigations, and project documentations

Job Requirements:

- Minimum Bachelor's Degree in Actuarial studies or related field

- Possess good working knowledge in Participating products, related local regulations and hand-on experiences in system implementation for bonus revision exercise

To apply, please email your resume in MS Word format to bfcg11@recruitexpress.com.sg indicating in your CV the following information:

Expected Salary:
Notice Required:
Reason for Leaving:

Only shortlisted candidates will be notified.

Jackie Ng May Ying (R1104602)

Recruit Express Pte Ltd

EA No: 99C4599

Non-CA Pay Range (Annual):

At Infinera, your base pay is one part of your total compensation package. Your actual base pay will depend on your skills, qualifications, experience, and location. This role may be eligible for equity grants, discretionary bonuses, or commission payments. The amount of these incentives is based on the terms of the Company’s incentive plans, the Company’s financial performance, and/or individual employee job performance.

Infinera also offers paid leave, medical, 

dental, and vision coverage, 401(k), life, and disability insurance and to

eligible employees.

The R&D Quality Director role requires a unique blend of management and hands-on expertise, serving as a vital bridge between Quality and R&D. We are seeking a seasoned professional with over 20 years of industry experience, including substantial exposure to both software and hardware development. The successful candidate will lead a team of three quality managers, closely partnering with R&D to drive continuous improvements in product quality and processes. This pivotal role ensures that quality remains at the forefront of R&D efforts, fostering excellence across the entire organization.

Key Tasks & Responsibilities:

Secure Quality in Products & R&D Programs

• Q target setting and monitoring
• Process tailoring to secure programs have optimum R&D processes in place and adequately supported and deployed
• Installation & execution of Program Quality Plans and use of metrics for monitoring and analysis of process performance
• Q-Gate readiness check; product quality reviews and audits to monitor and foster process adherence

Support R&D Process Management

• Support process management with subject matter expertise on international Q standards (e.g. TL, ISO) and best practices (e.g. left shifting)
• Support the development, assessment and implementation of key R&D product and process performance measures/metrics

Drive Continual Improvement

• Promote proactive key improvement quality practices
• Support product RCA analysis on field issues escalated to R&D
• Manage process improvement projects that are aligned with strategic goals
• Provide training as it relates to driving process improvements

Value add:

• Independent and neutral Q org to secure quality in products and R&D programs
• Seamless e2e Q workflow supported via Global Quality organization

KPIs:

• Customer-perceived KPIs (CFD, Outages…)
• Q KPIs (test execution rate, test pass rate, critical faults…)
• R&D KPIs (code coverage, defect density, code review effectiveness…)
• TL9K Metrics for certified Product Categories

Key interfaces:

• R&D / ProdM / Service Teams
• Global Q Community

Required Experience:

• 15+ years of experience in SW & HW Development
• Proven Q mgmt. approach with expertise on best in class Q practices & methods
• Experienced leadership re cross-functional / international teams
• Certified auditor
• ISO9K, TL9k, CMMI & Agile
• Jira, SFDC

#LI-DW

#LI-Hybrid

Infinera is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Infinera complies with all applicable state and local laws governing nondiscrimination in employment.

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. 

For our Bornem, Belgium | Lonza site, we have an open position for a R&D Project Engineer. In this role, you will develop and manage projects and transfer new process and system technologies to Capsugel affiliates. This includes working through the 5-phase development model, starting by generation of project functional requirements based on affiliate needs. Projects include own developments (with in-house project teams) or outsourced developments (through engineering offices).

Key responsibilities: 

New Process / System Development:

• Identify opportunities to utilize new process technologies to improve the existing HGC process or create new processes or products. New process technology may include: defining process flow, modelling process variables, equipment identification and specification including process control systems and providing capital cost estimation and cost benefits

• Identify project functional requirements working with affiliate management, engineering or outside technology resources

• Execute and/or manage projects from laboratory demonstrators and prototypes through manufacturing scale-up and operational phases, maintaining effective communication with development colleagues, project team members and outside technology resources

• Organize process technology design, prototyping and scale-up trials; perform required experimental design and analyses, identify critical process variables

• Correlate and interpret results and draw logical conclusions

• Define operating parameters which deliver a consistent process and product to required outcomes.

Process or systems technology transfer:

• Support implementation of new technology within Capsugel affiliates in conjunction with TS or divisional project teams

• Organize and execute process, systems, equipment or methods validation in support of technology transfer following Corporate and Capsugel guidelines

• Provide appropriate drawings, samples, process or equipment manuals in support of technology documentation packages.

Development and training:

• Assist in training and functional guidance of end users of new process technology and system development introductions

• Identify additional training requirements and arrange internal, external resources as required

• Design and prepare process or systems manuals to facilitate ‘top-class’ technology transfer practice within Capsugel.

Key requirements:

• Master or PhD (of science) in mechanical, electrical or chemical engineering

• Significant industrial experience including a proven project and systems development management record

• Fluent in English, good knowledge in Dutch and in French, German is an asset

• The job requires a presence every day on the site of Bornem

• Team player and hand on mentality

We are currently seeking an interim Science Technical Project Leader, to work with our global FMCG client's division, Elida Beauty, renowned for brands such as TIGI, VO5, Toni & Guy, and Brylcreem, and become an integral part of their fast-paced Scientific FMCG environment.

The position is based in the Knowledge Quarter in Liverpool City Centre (L3), accessible by train, bus and car. This is a full-time temporary role for 6 months (With potential to extend), requiring 37.5 hours per week, Monday to Friday. Compensation for this role is competitive, paying between £35,000 - £45,000 per annum, pro rata, depending upon experience.

Position Summary:

We are looking for a new member of the Product Delivery Team in Elida Beauty who will act as a Technical Project Leader on Sourcing and Savings projects, and as Scale-up engineer on Innovation projects, to help deliver a portfolio of innovative products across personal care that will delight the consumer. The Product Delivery team generally leads all sourcing and savings project, plus governs product scale-up qualification across all projects. This role will provide the opportunity to be involved in a diverse range of brands and consumer applications across our beauty and personal care brands.

Main Purpose of the Job:

• Lead and co-ordinate technical project workstreams to deliver against agreed Innovation and renovation road maps
• Technical leadership and accountability for the scale-up (overall qualification) of products into new manufacturing sites
• Ensure all developments not only meet business objectives, but are developed in a fully compliant way against all safety, regulatory and quality needs
• Identify new opportunities to deliver to consumer, customer and business needs - including but not limited to new and more sustainable product solutions

Role Accountabilities:

• Lead and land projects for Elida Beauty brands as acting as TPL
• Ensure that all the mandated product development protocols and stability requirements are addressed. Ensure that the products meet all the consumer safety & regulatory requirements.
• Manage the network along with the project team. Ensure proper risk assessment & mitigation plan is in place for assigned projects.
• Identify and bring to the organisation new business opportunities through novel thinking and understanding of consumer trends and needs. Must include, but not limited to, sustainability game changers and inclusive design.
• Work closely with other R&D functions to deliver assigned projects as well as broader product development capabilities, such as Product Logic Savings, Technical Capability building, Consumer test sample making, etc.
• Develop and maintain technical assessments of the environmental impact of and the risk involved in activities, including the success in terms of quality and OTIF.

• Manage end to end qualification activities of our manufacturing and product development partner organisation, from material selection, lab and pilot scale

• Product making, evaluation and testing, result analysis and reporting - through to main plant trials and first productions.
• Manage budgetary project requirements including partner activities.
• Manage the creation of specifications in Oracle PLM to fully capture all aspects of the product required for compliant high quality manufacture.
• Own aspects of our capability agenda making improvements to how we work, our knowledge and understanding of consumers, products and manufacture.
• Lead input of whole product related perspective to x-functional teams - ensuring risks are identified, understood and mitigated. Ensure timings and expectations of formulation related activities are ambitious and correctly recognised within project plans.

• Contribute to compelling consumer and customer insights and stories through connection with consumers. Support business through direct customer interactions and presentations where required.

Critical Competencies:

• 3+ years experience in technical product development roles, ideally in beauty / personal care FMCG. Experience acting as a TPL desirable.
• Self starter who brings a great inner game to work every day making a positive impact on those around them with great verbal and written communication skills.
• Ability to handle multiple complex projects at one time knowing where they can add value and where others need to.
• Ability to understand and simplify problems to their key component drivers, driving smart and innovative decision making.
• Ability to apply business leadership understanding and prioritise the impact of development choices considering factors such as cost, consumer experience and the environment.
• Experience within more than one functional area of R&D is desirable, e.g. formulation, product formulation, process scale-up, regulatory.
• Science or Engineering degree in a relevant field, or alternative transferable technical qualification.
• Track record of delivering products to market, through working with x-functional teams and external partners.

Job Title

Job Description

Cross-functional Core Team Leader responsible for the investigation and development of new medical device concepts supporting Philips Image Guided Therapy Devices business. 

You will work on a variety of technologies and peripheral vascular disease states with a primary focus on intravascular ultrasound technologies, device, and system development. 

Your role:

• Leading medium to large size projects within the Advanced Development portfolio supporting execution of the Peripheral Vascular Business strategic plan.

• Defining and managing project management plan in accordance with the product development process while maintaining the flexibility to optimize the project scope and strategy as needed during project execution.

• Assembling and leading project cross-functional core teams with skillsets required to deliver product development scope and meet organizational objectives. Functions include: PMO, R&D, Marketing, Quality, Regulatory, Industrialization and Clinical. 

• Advanced Development project focus includes:

  • Driving the discovery of unmet needs, markets, and technologies.

  • Defining opportunities through value proposition creation including establishing market models and concepts as well as key constraints, risks, and assumptions.

  • De-risking opportunities and demonstrating concept feasibility and safety.

  • Collaborating with R&D core teams to facilitate the hand-off of proven product concepts for further development within the formal Product Develop Process.  

• Managing key project constraints including scope, schedule, budget, and resources to investigate and develop safe and effective product concepts.

• Conducting project planning workshops to integrate cross-functional plans and managing team execution to meet project commitments.

• Actively managing project risk and incorporating in project plans to exploit opportunities and mitigate risks

• Effectively communicating project progress, decision making, and escalations to ensure both project team and stakeholder alignment.

• Actively managing stakeholders including expectations alignment and functional support across a multi-site project and senior leadership team.

• Supporting PMO and Advanced Development functional excellence initiatives.

• Providing guidance and coaching/mentoring to team members as well as partnering with functional management to ensure support for core team member development.

• Co-location with the project team and up to 10-15% travel depending on development scope of work and business needs.

You're the right fit if:

• You’ve acquired 7+ years of product development experience within the medical device industry with at least 2 development cycles as a project leader.

• Project Management experience as well as understanding and application of the product development lifecycle is required. Project Management Professional Certification (or equivalent) is a plus.

• You have strong organizational skills with a proven ability to lead and influence teams comprised of both technical and non-technical resources. The ability to communicate effectively (verbal and written) across all levels of the organization is required.

• Additional skills include planning and schedule management, project risk management, stakeholder management, problem solving, conflict management, and decision making. Working understanding of MS Project, ProChain, and schedule variance are a plus. Knowledge and experience with ultrasound and/or intravascular ultrasound technology is a plus.

• You have a Bachelor of Science in Engineering (Mechanical, Electrical, Electro-Mechanical or Biomedical); other degrees will be considered based on experience. Advanced degree (MS, PhD, or MBA) is a plus.

• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position. 

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

• Read more about our employee benefits.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

Philips Transparency Details

The pay range for this position is $130,000 to $223,000, annually.  The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.  

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found here. 

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to San Diego, CA.

#LI-PH1

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

Statistical Science Director - Early Oncology

Location: Macclesfield (UK)

Competitive salary and benefits

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

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

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 Organisations 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

Date advert opened: 11th March 2024

Date advert closed for applications: 4th April 2024

#CTord

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) 

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Job Title

Job Description

In dieser Position haben Sie die Möglichkeit

den Marktführer bei der Weiter- und Neuentwicklung der Produktlinie unserer Patientenüberwachungssysteme zu unterstützen, durch die Koordination der Integration von externen Partnerlösungen zur Vitalparameterüberwachung in unser Portfolio.

Sie arbeiten dabei in enger Kooperation mit den verschiedenen anderen Abteilungen in R&D, mit Marketing, Quality und Regulatory, sowie mit externen Partnern zusammen.

Diese Aufgaben erfordert sowohl technische Grundkenntnisse und die Fähigkeit sich schnell in technisch sehr vielfältige Gebiete einzuarbeiten, als auch herausragende Projektleitungsfähigkeiten, sowie exzellente Kommunikationsfähigkeiten in Deutsch und Englisch.

Engagement, Flexibilität, ein hohes Qualitätsbewusstsein und gute Zusammenarbeit mit vielfältigen Partnern ist für unseren Erfolg unumgänglich.

Für folgende Themen bekommen Sie die Verantwortung:

• Projektleitung für die Integration von externen Partnerlösungen zur Vitalparameterüberwachung. Erstellung von Projektdokumentationen im Rahmen des Qualitätssystems.

• Sie sind der erste Ansprechpartner für diese Lösungen sowohl für den externen Partner als auch für andere Bereiche von Philips.

• Abstimmung mit den internen und externen Projektteams.

• Durchführung der zugehörigen Zeitplanung und Allokation der entsprechenden Ressourcen und Budgets.

• Sicherstellung, dass die notwendigen Informationen, Spezifikationen, Prototypen und Dokumentationen für die Produktentwicklungen passend und rechtzeitig zur Verfügung stehen.

• Mitwirkung bei Vertragsverhandlungen.

Sie sind ein Teil:

der Philips Medizin Systeme Böblingen GmbH. Wir entwickeln und produzieren Patientenüberwachungssysteme für den weltweiten Markt. Diese kommen vor allem in der Notfall- und Intensivmedizin, der Schwangerschafts- und Neugeborenenüberwachung, bei Operationen und in der Anästhesie zum Einsatz. Unser Team im Bereich R&D Measurements leitet die Entwicklungsaktivitäten für marktführende klinische Messungen (u.a. EKG, Blutdruck, Temperatur, Sauerstoffsättigung), welche im Rahmen eines Monitoringsystems das klinische Personal bei der Überwachung, Diagnose und Therapie von Patienten unterstützt.

Um in dieser Position erfolgreich zu sein, benötigen Sie folgende Kenntnisse und Erfahrungen:

• Abgeschlossenes Studium in Elektrotechnik, Informatik, Medizintechnik oder einem Studiengang mit vergleichbaren Inhalten

• Mindestens 5 Jahre Berufserfahrung in der Projektleitung, idealerweise in der Entwicklung von Medizinprodukten

• Erfahrung in der Koordination von Projekten mit externen Technologiepartnern

• Sehr gute Kommunikations- und Konfliktlösungsfähigkeiten

• Kundenfokussierte und ergebnisorientierte Arbeitsweise

• Breites Verständnis und Erfahrungen mit einem Qualitätssystem (idealerweise für Medizinprodukte). Sehr hohes Qualitätsbewusstsein

• Kenntnisse / Erfahrungen mit Sicherheitsstandards und Produktzulassungen weltweit (CE/FDA)

• Verhandlungssichere Kenntnisse in Deutsch und Englisch

Dafür bieten wir dir

• zahlreiche Angebote im Rahmen unseres „Employer of Choice“ Programms (u.a. betriebliche Altersvorsorge, Familienservices, Gesundheitsprogramm, moderne Arbeitszeitmodelle). Als Unternehmen für Gesundheit und Wohlbefinden liegt Philips das Thema Vereinbarkeit von Beruf und Privatleben unserer Mitarbeiter*innen am Herzen.

• Eine abwechslungsreiche und herausfordernde Tätigkeit innerhalb eines motivierten, interdisziplinären Teams,

• ein attraktives Arbeitsumfeld mit Entwicklungsperspektiven in einem zukunftsträchtigen, krisensicheren Geschäftsbereich, 

• ein leistungsorientiertes Vergütungsmodell und ansprechende Sozialleistungen,

• eine offene Unternehmenskultur mit flachen Hierarchien und

• eine professionelle Einarbeitung sowie Fort- und Weiterbildungen.

Bitte bewerben Sie sich online mit Ihren vollständigen Unterlagen.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

# LI-EU

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

Job Title

Job Description

As a R&D Project Manager, you will work within the Program Management Team, reporting to the R&D Program Management Leader.

Your responsibilities will be to plan, execute, monitor, control and close R&D projects in a cross functional team. You may also lead transversal activities related to continuous improvement of the project management.

Your role:

• Prepare the project inputs with R&D internal customers (Product Management, Service Department)
• Prepare and participate to project Kick Off with all stakeholders
• Develop and maintain project plan, Gantt charts, project dashboards
• Identify risk areas, determine and implement mitigation actions for the risks identified.
• Facilitate meetings with task groups as required for cross functional projects
• Communicate high level, synthetic status reports of project progress, achievements and issues to all stakeholders
• Articulate decisions to be taken to keep the project moving forward
• Maintain projects KPIs with internal indicators or indicators built by the project team
• Provide post project completion analysis (cost, resources, lessons learned)
• Participate to the development or improvement of the different processes and tools related to project management

You're the right fit if:

• Fluent in both French and English, verbal, and written communication
• Ability to present accurate information succinctly in a compelling manner for a specific project
• Excellent interpersonal skills to successfully establish and maintain strong working relationships and consensus with all stakeholders not limited to R&D. 
• Excellent facilitation, team leadership, problem-solving skills are essential
• Expert in developing Gantt charts / project plans
• Excellent written and verbal communication skills
• Strong interpersonal, communications, presentation and negotiation skills
• Autonomous, team player, have strong organizational skills, with a track record of managing multiple projects effectively
• Endorse the sharing of information; cultivate cooperation and understanding for differing views and perspectives
• Ability to follow and propose/provide improvement to the development processes from the Quality Management System in place
• Ability to calculate a cost benefit analysis and project ROI
• Bachelor’s degree in Computer Science or related field required or significant experience
• Preferably 6+ years of Project Management
• Preferably experience in healthcare, automotive or aeronautics industry

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

***************************************************

En tant que R&D Project Manager, vous travaillerez au sein de la R&D dans l’équipe « Program Management » et vous reporterez au R&D Program Management Leader

Vos responsabilités seront de planifier, exécuter, contrôler et clore les projets R&D au sein d’une équipe pluridisciplinaire. Vous mènerez également des activités transversales d’amélioration continue relative au project management.

Votre rôle :

• Préparer les entrants du projet auprès des clients internes de la R&D (chefs de produit, département Service)
• Préparer et participer au lancement du projet (Kick-Off) avec toutes les parties prenantes
• Générer et maintenir le plan projet, le diagramme de Gantt et les différents tableaux de bord
• Identifier les risques, définir et suivre les différentes actions de mitigation de ces risques
• Avoir un rôle de facilitateur dans les réunions de travail de l’équipe pluridisciplinaire
• Communiquer à différents niveaux - selon des rapports synthétiques – de l’évolution du projet, des réalisations et des problèmes rencontrés
• Articuler les décisions à prendre pour faire avancer le projet
• Maintenir les différents indicateurs d’avancement des projets
• Réaliser une étude post-mortem du projet (coûts, ressources, leçons apprises)
• Participer au développement et à l’amélioration des différents processus et outils relatifs au project management

Vos atouts :

• Pratique courante du français et de l’anglais à l’écrit et à l’oral
• Savoir présenter les informations de façon succincte et convaincante
• Savoir établir avec succès et maintenir des relations de travail solides avec toutes les parties prenantes au sein et au-delà de la R&D
• Faire preuve de Leadership et de capacité à résoudre les problèmes au sein d’une équipe pluridisciplinaire
• Avoir de solides connaissances dans l'élaboration d’un plan projet et d’un diagramme de Gantt
• Avoir une excellente communication écrite et verbale
• Avoir une facilité de négociation, de communication et de présentation
• Avoir de l’autonomie, organiser son temps de manière à gérer différents projets simultanément
• Savoir partager l’information de manière circonstanciée ; favoriser une coopération fructueuse entre des personnes ne partageant pas les mêmes points de vue
• Respecter le système qualité de l’entreprise, être moteur sans son application par le reste de l’entreprise ; participer à son évolution
• Capacité à mener une analyse coût / bénéfice et calculer un ROI projet
• Diplôme d’ingénieur ou équivalent
• De manière préférable, 6 ans d’expérience en gestion de projet
• Une expérience préalable dans les domaines de la santé ou des transports serait un plu

#LI-EU

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