Senior Scientist Bioassay Development and Quality Control (Gene Therapy)

Location: Waltham, Massachusetts, United States; onsite

Salary: $100,500–$145,166.66 per year

Company

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

What you will do

• Develop, qualify, validate, and transfer potency methods for viral and non-viral gene therapies.
• 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 and reports, maintain electronic notebooks, and present technical findings.
• Manage quality events including deviations, change controls, and laboratory investigations.
• Collaborate with scientists, associates, management, CROs, and international analytical leadership 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 or stability assays.
• Ability to manage multiple quality events and maintain GMP and safety compliance.
• Experience in gene therapy analytics, including potency and impurity concepts, is preferred.
• Knowledge of data analysis and relative potency assay analysis, including regulatory expectations.

Nice to have

• Experience with flow cytometry, FRET assays, effector function assays, reporter cell lines, PCR, ELISA, or design of experiments approaches.
• Experience automating cell-based assays and performing structure/function or in-process studies.
• Experience transferring analytical methods to other sites.
• Experience with BioVia products.

Culture & Benefits

• Supportive, integrated, and future-focused R&D 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 and benefits package aligned with contribution and experience.