Director, Biologics Drug Product Development
About The Position
The Director of Biologics Drug Product Development leads technical development and optimization of drug products within Biogen’s Biologics portfolio. Within the BioATMP/Biologics drug product development team, this role oversees formulation, fill-finish processes, and primary packaging for new molecules, advancing them from pre-clinical stages through clinical development toward scalable, cost-effective commercial manufacturing. The role also leads the design of new drug products throughout their lifecycle and applies predictive models for molecule developability, process stability, and bio-performance to support patient-centric solutions. This strategic leadership position oversees direct and matrix reports working in internal laboratories and at CDMOs, manages critical regulatory submissions, and contributes to the department leadership team. The Director leads scientists, manages workload and productivity, coaches staff and supports career development, and fosters innovation in formulation and process technologies. The role works cross-functionally with GMTO-led tech transfer teams and influences drug substance, analytical development, and regulatory CMC activities.
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 of 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 design and development of parenteral dosage formulations from pre-clinical stages through commercial launch.
- Partner with GMTO-led tech transfer teams to influence and advance fill-finish development at internal and external sites.
- Lead scientists and manage 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 and contribute to the department leadership team.
Benefits
- Medical, dental, vision, and life insurance.
- Fitness and wellness programs, including fitness reimbursement.
- Short- and long-term disability insurance.
- At least 15 days of paid vacation and additional end-of-year shutdown time off from December 26 through December 31.
- Up to 12 company-paid holidays and 3 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
