Biologics Drug Product Development Director

Biogen, Inc.; Cambridge (MA); Sur place; USD 188 000 - 259 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Life insurance

Fitness reimbursement

Disability insurance

Paid vacation 15 days plus shutdown (D

Holidays

Sick time (80 hours)

Parental leave

401(k) match

Employee stock purchase plan

Tuition reimbursement

Employee Resource Groups

Résumé du poste

Biogen, Inc. seeks a Director of Biologics Drug Product Development to lead the technical development and optimization of biologics drug products across pre-clinical to clinical stages.

You will guide formulation, fill-finish, and primary packaging strategies, ensuring scalable, cost-effective manufacturing while shaping lifecycle design for new products. You will manage internal scientists and external partners, drive regulatory readiness, and influence decisions with cross-functional

Qualifications

• Bachelor’s degree and a minimum of 12 years of experience in biopharma drug product and combination drug product development.
• Expertise in liquid and lyophilized formulation development and commercialization.
• Proven experience in developing subcutaneous products integrated with delivery solutions.
• Extensive knowledge of global regulatory requirements for injectable product development.
• Experience in scale-up of aseptic drug product processes.
• Proven track record of working with external CDMO partners.
• Experience in developing process development and stability models for formulation performance.
• Strong analytical and problem-solving skills.
• Demonstrated leadership experience through managing a team and cross-functional collaboration.

Responsabilités

• Lead efforts in designing and developing parenteral dosage formulations from pre-clinical stages to commercial launch.
• Partner with GMTO-led tech transfer teams to influence and progress fill-finish development at internal and external sites.
• Provide leadership to scientists, managing workload, capacity, and productivity while fostering formulation and process technology innovation.
• Oversee staff performance, coaching for career development and participating in talent reviews and promotions.
• Drive innovation in developing technologies for challenging subcutaneous and combination drug-device products.
• Interact and influence drug substance, analytical development, and regulatory CMC activities at the Biologics Development level.

Connaissances

Drug product development

Biologics

Regulatory CMC

Leadership

Parenteral formulation

CDMO management

Formation

Bachelor's degree

Description du poste

Biogen, Inc. seeks a Director of Biologics Drug Product Development to lead the technical development and optimization of biologics drug products across pre-clinical to clinical stages.

You will guide formulation, fill-finish, and primary packaging strategies, ensuring scalable, cost-effective manufacturing while shaping lifecycle design for new products. You will manage internal scientists and external partners, drive regulatory readiness, and influence decisions with cross-functional