Director, Biologics Drug Product Development
About The Position
The Director of Biologics Drug Product Development leads technical development and optimization of drug products in Biogen’s Biologics portfolio. Within the BioATMP/Biologics drug product development team, this role guides formulations, fill-finish processes, and primary packaging for new molecules from pre-clinical development through clinical phases, with the goal of establishing scalable, cost-effective commercial manufacturing processes. The role also leads the design of new drug products across their lifecycle and applies predictive models for molecule developability, process stability, and bio-performance to support patient-centric solutions. This strategic leadership role oversees direct and matrix reports working in internal laboratories and with CDMOs, manages regulatory submissions, and participates in the department leadership team to advance innovation and talent development. The Director leads scientists and cross-functional efforts, influences technical development and regulatory CMC activities, and presents to executive management.
Requirements
- Bachelor’s degree.
- At least 12 years of experience in biopharma drug product and combination drug product development.
- Expertise in liquid and lyophilized formulation development and commercialization.
- Proven experience developing subcutaneous products integrated with delivery solutions.
- Extensive knowledge of global regulatory requirements for injectable product development.
- Experience scaling up aseptic drug product processes.
- Proven track record working with external CDMO partners.
- Experience developing process development and stability models for formulation performance.
- Strong analytical and problem-solving skills.
- Demonstrated leadership experience managing a team and collaborating cross-functionally.
Responsibilities
- Lead the design and development of parenteral dosage formulations from pre-clinical stages through commercial launch.
- Partner with GMTO-led technology-transfer teams to influence and advance fill-finish development at internal and external sites.
- Lead scientists by managing workload, capacity, and productivity, while fostering formulation and process technology innovation.
- Oversee staff performance, coach employees on career development, and participate in talent reviews and promotions.
- Drive innovation in technologies for challenging subcutaneous and combination drug-device products.
- Interact with and influence drug substance, analytical development, and regulatory CMC activities at the Biologics Development level.
- Oversee direct and matrix reports in internal laboratories and at CDMOs.
- Manage critical regulatory submissions.
- Participate in the department leadership team and drive innovation and talent development.
- Apply predictive models for molecule developability, process stability, and bio-performance.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Fitness and wellness programs, including fitness reimbursement
- Short- and long-term disability insurance
- At least 15 days of paid vacation
- End-of-year shutdown time off from December 26 through December 31
- Up to 12 company-paid holidays
- Three paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid maternity and parental leave
- 401(k) program with company-matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
- Short-term and long-term incentives, including cash bonus and equity incentive opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Director
