Analytical Sciences Associate

Responsibilities

• Perform routine analytical testing to support GMP release, stability, and product characterization programs, including cell-based potency assays, molecular assays (e.g., ddPCR), and/or biochemical assays (e.g., ELISA, CE, HPLC, Western blot), with primary depth in at least one assay category
• Execute assays in accordance with approved SOPs, test methods, and protocols, ensuring compliance with GMP documentation practices and data integrity (ALCOA+) requirements
• Review and verify analytical data for accuracy, completeness, and compliance with GMP documentation standards
• Collaborate cross-functionally to support method qualification, validation, and transfer activities in accordance with ICH, USP, and GMP guidelines
• Maintain laboratory and instrument readiness, including equipment calibration, maintenance tracking, reagent preparation, sample receipt and tracking, logbook documentation, and inventory management in compliance with GMP requirements
• Collaborate cross-functionally with manufacturing and QA to support method transfer, technical assessments, and data quality
• Support internal and external audits, regulatory inspections, and data requests as needed
• Train and mentor other analysts as needed

Requirements

• Bachelor's or Master's degree in Molecular Biology, Cell Biology, Biochemistry, Biotechnology, or a related discipline
• 3-8 years of relevant experience in Analytical Sciences or QC environment in the biopharmaceutical or gene therapy industry
• Familiarity with GMP documentation practices, data integrity principles, and regulatory expectations for biologics or gene therapy products
• Strong attention to detail, organizational skills, and ability to execute protocol-driven workflows in a regulated environment
• Effective communication and ability to work collaboratively in cross-functional GMP teams
• Hands-on experience in at least one of the following areas required, with working knowledge or exposure to others preferred: Cell-based potency assays, Molecular assays, or Biochemical assays (ELISA, CE, HPLC, Western blot)

Benefits

Health Care Plan (Medical, Dental & Vision)
Retirement Plan (401k)
Life Insurance (Basic, Voluntary & AD&D)
Paid Time Off (Vacation, Sick & Public Holidays)
Family Leave: (Maternity, Paternity)
Short Term & Long Term Disability
Training & Development
Stocked micro-kitchen with drinks and snacks
Wellness Resources