Senior Manager Quality Control- Biologics

Senior Manager Quality Control- Biologics

Vacancy expired!

Senior Manager Quality Control- Biologics 1124114

Job Scope & Purpose:

Our global biopharmaceutical client has recently constructed a state-of-the-art facility in Waltham and is currently seeking a Senior Manager of Quality Control. This position will be establishing a new lab to support release testing of cGMP manufacturing of drug substance and drug product, environmental monitoring, microbiology QC testing, and process deviation investigations.

Primary Job Responsibilities:

• Responsible for QC biochemistry, microbiology, bioassay, in-process, lot release, and stability testing of therapeutic bulk drug substance and final drug product laboratories
• Oversee laboratory investigations, deviations, CAPAs and troubleshooting
• Leading analytical methods development, methods qualification, and methods validation activities
• Leading QC related technical troubleshooting including deviation handling and investigations
• Act as subject matter expert for QC GMP operations during audits and regulatory inspections Maintain QC laboratories and facilities in audit and inspection readiness mode
• Generate, manage, evaluate, and maintain data in a highly organized manner
• Coordinate with cross-functional departments on various projects
• Interpret data and contribute to technical reports
• Identify technical issues and implement solutions
• Ensure high-quality, timely documentation in laboratory notebooks and technical reports

Primary Job Requirements:

• MS, or Ph.D. in related scientific field with 5 - 10 years of industry experience
• Strong hands-on experience with biochemistry testing, such as HPLC, ELISA, Bioassay, and CE-SDS testing in a regulated environment (GMP, GLP, etc.)
• Expertise working with Quality Systems and Document Management Systems
• Expertise leading methods development, methods qualification, OOS method investigations and methods validation activities
• Experience ensuring audit readiness, contributing to clients' regulatory filings, and supporting clients' audits and inspections
• Expertise working within cGMP compliance and providing GMP documentation
• Ability and desire to work in a fast-paced, start-up environment.
• Strong collaboration, team-working, documentation, and communication skills.
• Independently motivated and detail-oriented with good problem-solving ability.

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.



Code: TechOps

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or