Senior Scientist Bioassay Development and Quality Control (Gene Therapy)

Location: Waltham, Massachusetts, United States; onsite

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines through immunoscience, data, and digital platforms.

What you will do

• Develop, optimize, qualify, validate, and transfer bioassay methods for viral and non-viral gene therapy products.
• Perform early-stage GMP release testing, QC testing, stability assays, and analytical support testing.
• Serve as a subject matter expert for biological potency assays and quantitative bioassay analysis.
• Write SOPs, reports, and technical presentations while maintaining compliant electronic notebooks and documentation.
• Support deviations, change controls, laboratory investigations, GMP compliance, and laboratory safety.
• Collaborate with scientists, associates, and management across local and international matrixed teams.

Requirements

• PhD in Biological Sciences or a related field; a master's degree may be considered.
• At least 2 years of experience in a GMP environment is required.
• Bioassay development experience and experience with QC release and stability assays.
• Ability to manage quality events, including deviations, change controls, and laboratory investigations.
• Knowledge of gene therapy analytics, potency and impurity paradigms, regulatory guidance, and relative potency assay analysis.
• Experience with analytical support for structure/function and in-process studies, or technology transfer to other sites.

Nice to have

• Four or more years of relevant industry experience, including gene therapy.
• Experience with flow cytometry, FRET assays, effector function assays, reporter cell lines, PCR, or ELISA endpoints.
• Experience with DOE approaches, automation of cell-based assays, or BioVia products.

Culture & Benefits

• Supportive, integrated, and future-focused biopharmaceutical environment.
• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Opportunities to work with AI, data, and digital platforms in drug discovery.
• Rewards package and career development opportunities in gene therapy.