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Manager / Sr. Manager, Quality Control (Gene Therapy) 1155716 Job Scope & Purpose: Our client is seeking an experienced Biologics QC Manager or Senior Manager to partner with internal and external teams to ensure high levels of quality for all QC testing in support of release and stability of gene therapy products including lab investigations and assay validation. They will oversee QC testing in support of supply of both clinical and commercial phase gene therapies according to cGMP standards including FDA, EMA and ICH guidelines and industry best practices. This position requires an individual capable of partnering across the organization to establish an innovative manufacturing supply chain and deliver transformative medicine. Primary Job Requirements:
- BS with at least 6 years of related GMP Bio-therapeutic work experience or a Master's degree and at least 4 years of related experience
- Experience in clinical-phase or commercial cGMP biologic regulations; working knowledge of product development and clinical manufacturing requirements
- Experience in cell or gene therapy is preferred
- Ability to work well in a fast paced environment & oversee multiple priorities
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: TechOpsEEO EmployerApex 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 Vacancy expired!
