Sr./Prin Sci- Analytical Development 2078890

Location: Boston. MA (Onsite)

Focus: Gene Therapy

Job Overview: In this role, you’ll lead bioassay development for our clients’ gene therapy programs, manage CDMO collaboration, and support analytical CMC strategy in a fast-paced, innovative environment.

Primary Job Responsibilities:

• Lead development and validation of bioassays for release, stability, and characterization.
• Support process characterization and comparability studies.
• Manage investigations, data trends, and input into manufacturing issues.
• Provide expertise in cell-based potency assays and analysis tools.
• Oversee budgets, CDMO coordination, and team management.
• Draft and review SOPs, protocols, and quality documents.
• Contribute to CMC submissions and ensure global compliance.

Primary Job Requirements: 

• PhD in Biological Sciences or related field with 10+ years in gene therapy-focused analytical development.
• Proven experience in method development, validation, and QC testing.
• Skilled in cell-based assays, ddPCR, flow cytometry, ELISA, and enzymatic techniques.
• Strong multitasker in fast-paced, cross-functional environments.
• Clear communicator with ability to present data and recommendations effectively.
• Experienced in managing external CDMO and CTL collaborations.
• Proficient in statistical analysis tools like JMP and SAS.
• Solid knowledge of FDA, EMA, WHO, GMP, and ICH guidelines.
• Strong organizational, strategic thinking, and problem-solving abilities.

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 [email protected] or 844-463-6178.