Senior Manager, Quality Control Operations

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Apex Systems
Manager, Quality, Systems
Full Time

Job Description

Senior Manager of Quality Control 1194992

Job Scope & Purpose:

Our client is an innovator in the Cell Therapy space looking to add a Senior Manager of Quality Control. The ideal candidate will oversee QC testing to support clinical phase cell therapy product releases associated stability programs. This position requires expertise in activities related to a start-up and implementation of an in-house QC laboratory and laboratory program.

Primary Job Responsibilities:
  • Building the Quality Control unit, including integrating high-quality talent capable of developing and executing in-house analytical and environmental testing
  • Establish laboratory procedures for standard reference management, sample management and storage, environmental monitoring program, and other appropriate robust programs and procedures, as necessary
  • Establish a microbiological program, including testing for endotoxin, bioburden, sterility, microbial ID testing, raw materials, water, and environmental monitoring
  • Provide technical and operational expertise for training, product investigations, deviations, change controls, CAPA, and quality improvements to ensure product quality is met consistently
  • Contribute to appropriate sections of IND and BLA filings

Primary Job Requirements:
  • BS or MS with 7+ years of biopharmaceutical industry experience, including 4 years in an analytical testing laboratory and supervisory experience
  • Experience in execution, assessment, and troubleshooting flow cytometry
  • Experience with cell and gene therapy products
  • Experience in establishing Quality Control laboratories
  • Experience in regulatory inspections and clinical and commercial phase cell and gene therapy QC related regulations
  • Previous history managing relationships with internal departments, external vendors, and partners

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 .


Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

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Dice Id : apexsan
Position Id : BHJOB2374_1194992
Originally Posted : 2 months ago

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