Senior Bioassay Quality Control Specialist 968809 Job Scope & Purpose: Our Cambridge biotech partner is seeking an experienced QC professional with thorough experience using cell-based assay method validation and implementation. This individual will work with bioassays for cutting edge gene therapy potency analyses by using cell-culture, qPCR, ELISA, and flow cytometry. The bioassays will support a wide variety of vector manufacturing process tech transfers and QC assays. If you have a strong technical background and track record in QC with methods related to cell therapies than please consider applying! This is an exceptional opportunity to join an industry leading biotech team. Primary Job Responsibilities:
Support implementation analytical methods and support life cycle management of bio-analytical, cell-based, and immunological-based assays
Additional collaboration responsibilities will focus on manufacturing process technical transfer, in-process testing strategy, analytical and process comparability assessments
Support assay monitoring program focused on the proactive assessment of method performance, including re-evaluation of system suitability requirements and design of method robustness studies
Experience with statistical data analysis for method and process monitoring and reporting would be preferred
Support the technical review of change control documentation and reports, deviations, OOS and other manufacturing and laboratory investigations
Primary Job Requirements:
BS with 5+ years or MS with 2+ years in a biotechnology discipline
3+ years of experience in a GMP environment
Experience designing analytical method validations and method verification (USP/ICH/FDA/EU regulations)
A passion for addressing the critical unmet medical needs of patients
Self-directed individual who works with limited direction in a fast-paced, goal-oriented environment
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.
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 844-###-####-6178.