Director, CMC Product Development – Biologics (Biologics)

Location: Boston, MA, United States; hybrid schedule with a minimum of two days on-site per week, currently Tuesday and Wednesday

Salary: $217,000–$226,750 USD per year, plus a discretionary annual bonus and potential long-term incentive award.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Define and execute biologics drug product CMC strategies across formulation, fill-finish, container-closure, and applicable device development.
• Lead formulation development for protein therapeutics, including excipient screening, optimization, forced degradation, and compatibility studies.
• Oversee process development, scale-up, technology transfer to CDMOs, process characterization, and validation readiness.
• Author and review drug product sections for IND, BLA, and Type A/B meeting submissions and support FDA and EMA interactions.
• Govern CDMO relationships, clinical supply coordination, change controls, deviations, packaging, labeling, and cold-chain planning.
• Partner with Analytical Development, Drug Substance, Quality, Clinical Operations, and Supply Chain on integrated CMC delivery.

Requirements

• Ph.D. in Pharmaceutical Sciences, Biochemistry, Chemical Engineering, or a closely related discipline, or equivalent work experience.
• 10+ years of CMC biologics experience with expertise in drug product formulation and/or fill-finish process development.
• Deep knowledge of protein stability, aggregation mitigation, excipient selection, lyophilization, and container-closure systems.
• Knowledge of ICH Q8/Q9/Q10/Q11, biologics CMC guidelines Q5A–Q5E, and FDA/EMA drug product development expectations.
• Experience managing biologics drug product CDMOs, including fill-finish operations, scale-up, process qualification, and commercial readiness.
• Strong senior-level stakeholder management, regulatory writing, scientific communication, and ability to influence without authority.

Nice to have

• Experience with lyophilized and liquid parenteral biologic formulations.
• Experience with primary packaging compatibility and extractables and leachables assessments.
• Experience evaluating prefilled syringes, autoinjectors, and other novel drug delivery technologies.
• Experience in pre-commercial, resource-constrained environments and infrastructure building.

Culture & Benefits

• Collaborative work across Research, Clinical, Regulatory, Quality, and external partners in a matrixed organization.
• Health and wellness coverage tailored to the country and region of hire.
• Paid time off, public holidays, and additional leave in accordance with local requirements.
• Hybrid work arrangements and flexible scheduling.