Associate Director, Analytical Development (Bioassay)

Location: Bridgewater, New Jersey, United States; full-time, in-person presence required

Salary: $155,000–$201,500 annual

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Lead the development, phase-appropriate validation, and troubleshooting of potency and impurity assays for biologic products.
• Provide scientific and technical leadership for the biological characterization of monoclonal antibodies, fusion proteins, enzymes, and other biologics.
• Serve as CMC analytical leader and liaison, communicating scientific strategy, risks, and results to senior leadership and cross-functional stakeholders.
• Manage laboratory activities, CRO/CDMO relationships, technical transfers, timelines, and quality requirements.
• Build, mentor, and develop a high-performing team of scientists.
• Author and review analytical sections of IND, IMPD, MAA, and BLA submissions and support regulatory interactions.

Requirements

• Ph.D. in Biochemistry, Molecular Biology, or a related life sciences discipline with 3+ years of relevant industry experience, or an M.S. with 7+ years of experience.
• Leadership experience in bioassay design and development, biologics characterization, and analytical method development in a biopharmaceutical setting.
• Expertise in GMP requirements and regulatory expectations for biologics, including potency assays and biological characterization.
• Experience managing and mentoring scientific teams, influencing cross-functional stakeholders, and managing CROs or CMOs.
• Strong strategic thinking, problem-solving, decision-making, written communication, and verbal communication skills.
• Ability to work full-time in person from the Bridgewater, New Jersey office.

Culture & Benefits

• Medical, dental, vision, and mental health support.
• Annual wellbeing reimbursement and Employee Assistance Program access.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with company match, annual equity awards, ESPP participation, and company-paid life and disability insurance.
• Learning programs, mentorship, employee resource groups, service programs, and volunteer opportunities.