Research Scientist I, Analytical Development 2063752

Location: Waltham, MA (Onsite)

Therapeutic Area: Gene Therapy

Job Overview: This scientist will lead bioassay development, manage validation processes, oversee external partnerships, and contribute to regulatory documentation.

Primary Job Responsibilities:

• Manage development, transfer, and validation of biological assays for release/stability testing, in-process checks and extended characterization, ensuring compliance and integration of studies.
• Lead process optimization and product comparability studies.
• Oversee creation and approval of SOPs and related documentation for QC lab transfers.
• Conduct rigorous selection of vendors for assay development and analytical testing.

Primary Job Requirements:

• BS in Biological Sciences with 6+ years in biotech or pharma, focusing on analytical development for biologics.
• Proficient in analytical methods (cell-based, enzymatic assays, ELISA, ddPCR) and familiarity with HPLC/UPLC, CE-SDS.
• Demonstrated project management skills and problem-solving, with experience in gene therapy process development.
• Skilled in CDMO/CTL management, statistical tools, and knowledgeable in FDA, EMA, GMP, WHO, and ICH guidelines, with strong communication.

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 employeeservices@apexsystems.com or 844-463-6178.