Total 11 Senior Executive microbiologist job vacancies in The United States of America

Purpose

Act as the site microbiology subject matter expert; provide microbiologist expertise and develop monitoring strategy and operation framework.

Ensure that all site utilities, water, environmental monitoring and product testing activities are properly analysed and executed, and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards.

Responsibilities

• Ensures that all water, environmental monitoring, site utilities and product testing samples are analysed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions. Develops a strategy for the site with respect to environmental monitoring and water systems. Perform microbiological risk assessment for all non-sterile products.
• Work with relevant functions to support method validation / verification for micro related methods, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Ensures that external service providers and suppliers for microbiology laboratory are managed in accordance to GSK requirements.
• Contribute to the formulation and development of the operational framework of the labs (framework covers testing protocol, SOP, and other operational policies, procedures and guidelines), and implement the approved plan.
• Contribute and occasionally lead site and corporate projects in line with specifications and budget allocation.
• Ensure a safe working environment for the laboratory and perform 5S and Zoning inspection.
• Supervise, develop, and motivate assigned analysts to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
• Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology Subject Matter Expert (SME).
• Ensure timeliness and accuracy of the Compliance review of Pharmacopoeia & ATS and to ensure In place and In use of the Pharmacopoeia / ATS / QMS requirement.
• Lead or participate in investigation arising from micro related and utilities investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations on remedial actions for follow-up.
• Work with the relevant R&D groups to support micro related activities and micro risk assessment for New Product Introduction, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Work closely with external staff and at line level to enable the localization and transfer of technology / knowledge / methodologies into standard order fulfillment activities.

Knowledge, Skills, and Experience

• Min degree in microbiology, chemistry, or life sciences
• Min 3 years of experience in an analytical environment in pharmaceutical or life sciences industry
• Experience in GMP
• Basic knowledge and on-going awareness of regulatory requirements (includes safety) on controlled environment and water system
• Very good knowledge of microbiological test methods
• Good knowledge of manufacturing processes and plant layouts of GlaxoSmithKline Manufacturing
• Good communication skills
• Basic financial management skills
• People Management skills

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore

#Li-GSK

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. ​

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.​

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Purpose

Act as the site microbiology subject matter expert; provide microbiologist expertise and develop monitoring strategy and operation framework.

Ensure that all site utilities, water, environmental monitoring and product testing activities are properly analysed and executed, and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards.

Responsibilities

• Ensures that all water, environmental monitoring, site utilities and product testing samples are analysed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions. Develops a strategy for the site with respect to environmental monitoring and water systems. Perform microbiological risk assessment for all non-sterile products.
• Work with relevant functions to support method validation / verification for micro related methods, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Ensures that external service providers and suppliers for microbiology laboratory are managed in accordance to GSK requirements.
• Contribute to the formulation and development of the operational framework of the labs (framework covers testing protocol, SOP, and other operational policies, procedures and guidelines), and implement the approved plan.
• Contribute and occasionally lead site and corporate projects in line with specifications and budget allocation.
• Ensure a safe working environment for the laboratory and perform 5S and Zoning inspection.
• Supervise, develop, and motivate assigned analysts to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
• Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology Subject Matter Expert (SME).
• Ensure timeliness and accuracy of the Compliance review of Pharmacopoeia & ATS and to ensure In place and In use of the Pharmacopoeia / ATS / QMS requirement.
• Lead or participate in investigation arising from micro related and utilities investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations on remedial actions for follow-up.
• Work with the relevant R&D groups to support micro related activities and micro risk assessment for New Product Introduction, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Work closely with external staff and at line level to enable the localization and transfer of technology / knowledge / methodologies into standard order fulfillment activities.

Knowledge, Skills, and Experience

• Min degree in microbiology, chemistry, or life sciences
• Min 3 years of experience in an analytical environment in pharmaceutical or life sciences industry
• Experience in GMP
• Basic knowledge and on-going awareness of regulatory requirements (includes safety) on controlled environment and water system
• Very good knowledge of microbiological test methods
• Good knowledge of manufacturing processes and plant layouts of GlaxoSmithKline Manufacturing
• Good communication skills
• Basic financial management skills
• People Management skills

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore

#Li-GSK

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. ​

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.​

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Purpose

Act as the site microbiology subject matter expert; provide microbiologist expertise and develop monitoring strategy and operation framework.

Ensure that all site utilities, water, environmental monitoring and product testing activities are properly analysed and executed, and the results recorded in full compliance with current Good Manufacturing Practice (cGMP) and regulatory requirements that meet the defined quality standards.

Responsibilities

• Ensures that all water, environmental monitoring, site utilities and product testing samples are analysed and tested according to the stipulated quality requirements so as to provide accurate test results for correct usage decisions. Develops a strategy for the site with respect to environmental monitoring and water systems. Perform microbiological risk assessment for all non-sterile products.
• Work with relevant functions to support method validation / verification for micro related methods, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Ensures that external service providers and suppliers for microbiology laboratory are managed in accordance to GSK requirements.
• Contribute to the formulation and development of the operational framework of the labs (framework covers testing protocol, SOP, and other operational policies, procedures and guidelines), and implement the approved plan.
• Contribute and occasionally lead site and corporate projects in line with specifications and budget allocation.
• Ensure a safe working environment for the laboratory and perform 5S and Zoning inspection.
• Supervise, develop, and motivate assigned analysts to help realize their maximum potential so as to contribute towards achieving the objectives of the department.
• Ensure regulatory compliance, perform L1 audit and support L2/L3/L4 audit as Microbiology Subject Matter Expert (SME).
• Ensure timeliness and accuracy of the Compliance review of Pharmacopoeia & ATS and to ensure In place and In use of the Pharmacopoeia / ATS / QMS requirement.
• Lead or participate in investigation arising from micro related and utilities investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations on remedial actions for follow-up.
• Work with the relevant R&D groups to support micro related activities and micro risk assessment for New Product Introduction, ensuring that the activities are carried out in accordance to the required standards and procedures.
• Work closely with external staff and at line level to enable the localization and transfer of technology / knowledge / methodologies into standard order fulfillment activities.

Knowledge, Skills, and Experience

• Min degree in microbiology, chemistry, or life sciences
• Min 3 years of experience in an analytical environment in pharmaceutical or life sciences industry
• Experience in GMP
• Basic knowledge and on-going awareness of regulatory requirements (includes safety) on controlled environment and water system
• Very good knowledge of microbiological test methods
• Good knowledge of manufacturing processes and plant layouts of GlaxoSmithKline Manufacturing
• Good communication skills
• Basic financial management skills
• People Management skills

To learn more about Singapore GSK and our people, please click on this link: https://www.linkedin.com/company/glaxosmithkline/life/gsksingapore

#Li-GSK

Why Us?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. ​

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.​

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Job Description

A Clinical Microbiologist position is available at KK Women’s and Children’s Hospital (KKH) in Singapore.

KKH is an 830-bed tertiary-level care hospital that provides obstetric, gynaecological, paediatric and other services. It is part of the SingHealth group of public hospitals. As an academic medical centre, KKH is a teaching hospital for Duke-NUS Graduate Medical School, Yong Loo Lin School of Medicine and Lee Kong Chian School of Medicine.

The position is based at the Department of Pathology and Laboratory Medicine (DPLM), which provides a range of comprehensive laboratory services to KKH and includes the Microbiology Service of which this position is a part.

The Clinical Microbiologist will be part of a team of two microbiologists. They will provide diagnostic and consultative clinical microbiology services to the hospital and participate in teaching, research, quality improvement and administrative activities commensurate with the activities of an academic medical centre. The activities range from bench-level advice and management of the clinical microbiology service, quality control of a medical diagnostic laboratory to communication of critical microbiology results, antimicrobial treatment advice and other consultative services to staff of all clinical disciplines in the hospital. This includes regular interaction with the hospital’s infectious diseases service and the infection control unit, and close collaboration with the other laboratory disciplines.

Requirements

You should be a qualified and experienced medical specialist with relevant quali­fications that are registrable with the Singapore Medical Council, and have a specialist qualification in Microbiology (Pathology/Laboratory Medicine) that can be recognised by the Specialists Accreditation Board.

Also, you should have at least one first-author publication in a peer-reviewed journal and have competent clinical skills with the ability to make sound and independent decisions.

The position is available up to Senior Consultant level.

Employment will be made commensurate with the qualifications and experience of the candidate.

Informal enquiries can be directed to A/Prof Kenneth Chang, Head of Department (kenneth.chang.t.e@singhealth.com.sg) or A/Prof Matthias Maiwald, Head of Microbiology (matthias.maiwald@singhealth.com.sg).

Key Responsibilities:

• Assist to manage / supervise the work of subordinate staff to provide microbiological and biological testing services to ensure successful performance and timely delivery of the study results
• Develop and validate new test methodologies
• Review test data and prepare test reports
• Handle enquiries and quotation as well as interface with customers on sample submissions, job status, technical matters
• Ensure compliance with laboratory quality management (ISO 17025, OECD GLP and GMP) and safety guidelines
• Ensure staff competency for the testing services
• Review and develop SOP
• Perform CAPA for non-conformance in laboratory
• Oversee the proper upkeep and maintenance of test equipment and instruments

Key Requirements:

• Minimum a Degree in Microbiology, Biological Sciences or related disciplines
• Preferably 3-5 years of work experience in Microbiological Testing laboratories
• Familiarity with ISO 17025 quality management system and OECD GLP & GMP quality system would be advantageous
• Results and service-oriented individual who possesses initiative and good communication skills
• A proactive team player but with the ability to work independently in challenging projects and timelines
• Enthusiastic and resourceful with a "can-do" attitude

Relocation Assistance Eligible:

Referral Payout Eligible:

Continue growing with our family. 

Our team members make it happen. If you want to continue to grow in a new role internally and see a position that looks right for you, we encourage you to apply!

Thanks for your commitment to Tyson Foods. 

Management Level:

Summary:  This position is responsible for various day to day tasks in the laboratory.  Responsibilities will vary from performing one procedure or work instruction to a number of chemistry, analytical, microbiological or quality system procedures or work instructions in a Food Safety Laboratory.  Precision and accuracy in performance of applicable work instructions and data collection is essential as well as demonstrating  proficiency and growth after training.  Team members with this position title must demonstrate leadership skills and work on complex work instructions and sophisticated equipment without close supervision as well as resolve routine problems.  Major areas of responsibility include assisting in validation and evaluation of new or existing testing applications and test results, assisting in statistical analysis of lab data, participating in the training of new employees, troubleshooting and performing basic maintenance and repair of electrical and mechanical equipment, maintaining ISO records for process control to comply with quality system and safety requirements, and performing tasks that are necessary to laboratory function and are generally considered to be management level tasks, such as reporting, communicating with customers, conducting special projects, etc.  Additional expectations for this position are the ability to work independently and resolve routine problems and, through cross-training, be capable of substituting for absent team members in specific areas, while complying with quality system and safety requirements.

Requirements

Education:  Minimum of high school diploma (or equivalent experience) required.  College level courses or degree in Chemistry, Microbiology or a related science field preferred.

Experience:  Previous laboratory experience (approximately 4 years) or technical training in a related field required.  Completed rotations through all areas of the General Microbiology and Pathogen laboratories required.

Communication Skills: Good reading, verbal, and written communication skills are required.

Computer Skills:  Working knowledge of Microsoft Office and LabWare LIMS applications.

Travel:  None

Please note:   Approximately one out of every four Saturdays, will work be required.

Work Shift:

Tyson is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will be considered without regard to race, national origin, color, religion, age, genetics, sex, sexual orientation, gender identity, disability or veteran status.

We provide our team members and their families with paid time off; 401(k) plans; affordable health, life, dental, vision and prescription drug benefits; and more.

Job Info:

• Basic: $3500 - $4500 + AWS + VB
• Working Hour: 5 days (Monday to Friday or Tuesday to Saturday) - 8:30am to 6pm / 9:00am to 6:30pm
• Location: Woodlands Industrial Park

Job Scope:

• To assist the lab manager to ensure that the Laboratory area operates efficiently and effectively through efficient organization of workflow
• Prioritization of urgent and regulatory related testing
• Efficient utilization of available resources
• To assist the lab manager to ensure that resource requirements are met for the Laboratory area through
• Co-ordinate staff so that the team’s KPIs are met in relation to TATs and specific customer requirements
• Ensuring that suitably qualified and/or trained staff are available to meet TAT requirements
• Ensure that the lab manager is fully aware of any operational or productivity issues as and when they arise
• Laboratory’s procedures are to be reviewed and updated as required
• Validates and releases test reports to customers
• To work as an effective and fully contributing team member, to assist other team members as time allows
• To assist the lab manager to carry out planned training for test procedure, equipment operations and other laboratory operation procedures for technicians and other staff of the laboratory
• Technical trouble shooting related to test method or equipment problems
• To write method or equipment validation protocol and execute
• To initiate or revise procedures and forms
• Carry out method validations
• To attend all regular team meetings
• To demonstrate the leadership & teamwork when appointed by lab manager for any ICs
• Ensure clarity and alignment of roles and ensure the efficient deployment of staff resources and foster a culture of continuous quality improvement
• To ensure that systems implemented are adhered to and monitored in conjunction with Quality & Compliance Department
• Work closely with Quality and Compliance Department on Quality issues and Quality improvements
• To ensure that any customer / sales/ ASM enquiries and/or issues/complaints are responded to in a timely fashion and that customers / sales/ ASM are aware of any delays in testing
• To ensure that all internal and external audits are completed with the team together if needed
• To ensure that all corrective actions assigned from internal and external audits are completed as required.
• Participate in workplace safety management practices to improve safety and health in the workplace environment to keep yourself and others safe, and to achieve continuous improvement and recognition of best practice
• Maintain equipment by performing assigned maintenance activities & troubleshoot unexpected problems

Please submit your updated resume by using the APPLY NOW BUTTON

By submitting your personal data and/or resume to us in connection with your job application, you will be deemed to have agreed and consented to us in collecting, using, retaining, and disclosing your personal data and/or resume to prospective employers for the purpose of the evaluating, processing and administration by company relating to this job application.

*We regret to inform you that only shortlisted candidates would be notified*

We wish you all the best in your career search.

You are welcome to visit our website at http://www.rkgroup.sg/

RK Recruitment Pte Ltd | EA License No.: 20C0280

Chou Jia Hooi | EA Personnel No.: R23115147

Roles & Responsibilities

• To assist the lab manager to ensure that the Laboratory area operates efficiently and effectively through: Efficient organization of workflow, Prioritization of urgent and regulatory related testing, Efficient utilization of available resources.
• To assist the lab manager to ensure that resource requirements are met for the Laboratory area through: Co-ordinate staff so that the team’s KPIs are met in relation to TATs and specific customer requirements, Ensuring that suitably qualified and/or trained staff are available to meet TAT requirements, Ensure that the lab manager is fully aware of any operational or productivity issues as and when they arise.
• Laboratory’s procedures are to be reviewed and updated as required.
• Validates and releases test reports to customers.
• To work as an effective and fully contributing team member, to assist other team members as time allows
• To assist the lab manager to carry out planned training for test procedure, equipment operations and other laboratory operation procedures for technicians and other staff of the laboratory.
• Technical trouble shooting related to test method or equipment problems.
• To write method or equipment validation protocol and execute.
• To initiate or revise procedures and forms.
• Carry out method validations.
• To attend all regular team meetings.
• To demonstrate the leadership & teamwork when appointed by lab manager for any ICs.
• Ensure clarity and alignment of roles and ensure the efficient deployment of staff resources and foster a culture of continuous quality improvement.
• To ensure that systems implemented are adhered to and monitored in conjunction with Quality & Compliance Department.
• Work closely with Quality and Compliance Department on Quality issues and Quality improvements
• To ensure that any customer / sales/ ASM enquiries and/or issues/complaints are responded to in a timely fashion and that customers / sales/ ASM are aware of any delays in testing.
• To ensure that all internal and external audits are completed with the team together if needed.
• To ensure that all corrective actions assigned from internal and external audits are completed as required.
• Participate in workplace safety management practices to improve safety and health in the workplace environment to keep yourself and others safe, and to achieve continuous improvement and recognition of best practice.
• Maintain equipment by performing assigned maintenance activities & troubleshoot unexpected problems.

Qualifications and Education Requirements

• Educational Background in Bio/Life Sciences & Microbiology, or Bio-Tech / Bio-Molecular Education.

• At least 3 to 5 years of Related Role/Work in related industries.

• Experience in both Micro-Biology as well as Bio-Molecular Work will be a huge advantage.

• Existing Technical Signatories for Microbiology &/or Bio-Molecular will be a plus.

Attitude and Aptitude Requirements

• A Passionate & Hardworking Individual willing to grab the opportunity to work with a Young & Energetic Team in one of the fastest growing lab & pharmaceutical company (Eurofins Scientific) that is expanding their reaches in the South-East-Asia (SEA) Region. Expect Fast Pace & Development.

• Foresight on future personal growth & tenancy to be committed for hard work and grind with the team.

• Passion in Microbiology & or PCR, and excited to be involved in & learning state of the art technology (e.g. ddPCR) and be ambitious enough to take on new PCR Projects/Tenders & other Method Development with existing knowledge. We empower young & energetic individuals to perform and be creative in their endeavors, coupled with their existing experience/s & good practices they can bring from their background.

Job Highlights:

• Opportunity to travel within SEA regions
• Up to $9K + AWS + VB

Job Responsibilities:

• Conduct technical visits and site survey to review customers' processes and disinfection products to ensure its efficiency and compliance.
• Assist customer in change control process including technical documentations for SOPs, validation training.
• Provide technical expertise across a broad base of application to resolve complex customer problems.
• Prepare documentations for any recommendations to support changes.
• Conduct seminars and internal training on GMPs, Microbiology, testing, cleaning and disinfection.
• Interface directly with Corporate Account Managers to ensure deliverables that meet the customer needs. Take part in sales presentations and support
• Provide leadership on unique customer projects which are beyond the expected technical ability of Account Managers or Regional Managers
• Responsible for ensuring brand standards and awareness, accuracy and completion of final reports in a timely manner

Job Requirements:

• Master's degree in Life Science, Microbiology or equivalent
• Experience or familiarity with the Life Sciences industry (Pharmaceutical and/or Personal Care)
• Demonstrated proficiency with internal or external auditing
• Knowledge/experience of change control processes
• Ability to take initiative, work independently and prioritize multiple projects with strong follow-through
• Flexibility to work on and control different projects at the same time while still meeting set deadlines
• Good knowledge of EN/ AOAC disinfectant efficacy standard test methods and mode of action of disinfectants
• Previous experience in GMP production sites Understanding regulatory compliance frameworks (e.g. MHRA, FDA, HPRA)

If you are keen to explore this career opportunity, kindly send a copy of your resume to rrkc(at)rapidrecruitmentasia.com or simply click the button to APPLY NOW! We regret that only shortlisted applicants will be notified.

Chan Ku Ci - R22111446

EA License No: 16C8261

Aegros is Latin for ‘Patient’. We chose this name because it speaks to our focus on the patient. Every day we strive to place the patient first by providing therapeutic plasma products they would not otherwise be able to access.

At Aegros we believe access to life saving therapeutic plasma drugs is a human right and not a privilege. In a nutshell our mission is to put the patients first through innovation.

Over 30 years we have developed our HaemaFrac™ process which enables countries to turn human plasma they collected into life saving hyperimmune products.

It's no secret that Aegros is expanding rapidly! An exciting opportunity has arisen for a Senior Microbiologist to join our Quality Compliance team. Working with the QC team you will be involved in setting up Micro and PC2 laboratory.

Reporting to the Quality Control Manager, this newly created Senior Microbiologist role is an important addition to our expanding team here in Sydney as we experience rapid growth across the organisation. You will be developing and performing microbiological and biochemical analysis of in process, finished product and incoming raw materials and utility samples. We are looking for a highly organised and focused team player who understands the importance of delivering on time and contributing to our success...!!!!

What you will be involved in………

• Planning and executing method validation, verification and improvements to method functionality
• Generating validation protocols and reports ensuring practices meet regulatory standards (TGA & ICH)
• Undertaking IQ, OQ, PQ
• Conducting method development and validation on Microbiology equipment
• Working closely with other departments to ensure all activities are completed
• Manage the performance of validation activities associated with changes to existing and new processes
• Developing and assessing microbiological testing procedures of materials and products, ensuring all GMP, safety, corporate, regulatory and legislative compliance requirements are met
• Managing audit preparations and providing support to defend areas of validation
• Monitoring the environment for signs on contamination such as mould growth or elevated bacteria counts
• Developing and assessing the maintenance, updating and validation of procedures involving environmental monitoring, equipment cleaning and sanitization
• Flexible to work is shifts across the day on a rotating roster
• Performing any other duties assigned by manager or delegates.

What we would expect from you:

• A Bachelor of Science degree majoring in Microbiology or related fields
• Demonstrated experience working within the pharmaceutical industry
• Proven experience within method development and validation in Microbiology
• Excellent written and verbal communication skills
• The ability to work independently.

Here’s what we can offer you…

• An environment which allows the individual to grow alongside the company
• A role that provides the bandwidth to explore innovative solutions while keeping patients at the centre of everything we do
• The chance to work with global industry experts in an organisation where success will be defined not just on successful delivery of goals but on how they were achieved
• A multicultural environment where every voice is heard
• Competitive remuneration package which includes an annual Bonus + Employee Share Options
• Close to public transport

Interested? Apply today...!!!!

Roles & Responsibilities

• To assist the lab manager to ensure that the Laboratory area operates efficiently and effectively through: Efficient organization of workflow, Prioritization of urgent and regulatory related testing, Efficient utilization of available resources.
• To assist the lab manager to ensure that resource requirements are met for the Laboratory area through: Co-ordinate staff so that the team’s KPIs are met in relation to TATs and specific customer requirements, Ensuring that suitably qualified and/or trained staff are available to meet TAT requirements, Ensure that the lab manager is fully aware of any operational or productivity issues as and when they arise.
• Laboratory’s procedures are to be reviewed and updated as required.
• Validates and releases test reports to customers.
• To work as an effective and fully contributing team member, to assist other team members as time allows
• To assist the lab manager to carry out planned training for test procedure, equipment operations and other laboratory operation procedures for technicians and other staff of the laboratory.
• Technical trouble shooting related to test method or equipment problems.
• To write method or equipment validation protocol and execute.
• To initiate or revise procedures and forms.
• Carry out method validations.
• To attend all regular team meetings.
• To demonstrate the leadership & teamwork when appointed by lab manager for any ICs.
• Ensure clarity and alignment of roles and ensure the efficient deployment of staff resources and foster a culture of continuous quality improvement.
• To ensure that systems implemented are adhered to and monitored in conjunction with Quality & Compliance Department.
• Work closely with Quality and Compliance Department on Quality issues and Quality improvements
• To ensure that any customer / sales/ ASM enquiries and/or issues/complaints are responded to in a timely fashion and that customers / sales/ ASM are aware of any delays in testing.
• To ensure that all internal and external audits are completed with the team together if needed.
• To ensure that all corrective actions assigned from internal and external audits are completed as required.
• Participate in workplace safety management practices to improve safety and health in the workplace environment to keep yourself and others safe, and to achieve continuous improvement and recognition of best practice.
• Maintain equipment by performing assigned maintenance activities & troubleshoot unexpected problems.

Qualifications and Education Requirements

• Educational Background in Bio/Life Sciences & Microbiology, or Bio-Tech / Bio-Molecular Education.

• At least 3 to 5 years of Related Role/Work in related industries.

• Experience in both Micro-Biology as well as Bio-Molecular Work will be a huge advantage.

• Existing Technical Signatories for Microbiology &/or Bio-Molecular will be a plus.

Attitude and Aptitude Requirements

• A Passionate & Hardworking Individual willing to grab the opportunity to work with a Young & Energetic Team in one of the fastest growing lab & pharmaceutical company (Eurofins Scientific) that is expanding their reaches in the South-East-Asia (SEA) Region. Expect Fast Pace & Development.

• Foresight on future personal growth & tenancy to be committed for hard work and grind with the team.

• Passion in Microbiology & or PCR, and excited to be involved in & learning state of the art technology (e.g. ddPCR) and be ambitious enough to take on new PCR Projects/Tenders & other Method Development with existing knowledge. We empower young & energetic individuals to perform and be creative in their endeavors, coupled with their existing experience/s & good practices they can bring from their background.