Senior Director, Biologics Drug Product Development

TalentAlly; Cambridge (MA); On-site; USD 188,000 - 259,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Fitness Reimbursement

Short- and Long-Term Disability

Paid Vacation

Holiday Time Off

Parental Leave

401(k) matching

Employee Stock Purchase Plan

Tuition reimbursement

Job summary

Biogen in Cambridge, MA seeks a Director of Biologics Drug Product Development to lead formulation, fill-finish, and packaging development across the lifecycle. You will guide molecules from pre-clinical to clinical phases toward scalable commercial manufacturing, while shaping new product designs and applying developability and stability models.

You will manage internal scientists and external CDMOs, oversee regulatory submissions, and contribute to department leadership and talent development

Qualifications

• 12+ years in biopharma drug product and combination development.
• Expertise in liquid and lyophilized formulations.
• Experience in subcutaneous products with delivery solutions.
• Global regulatory knowledge for injectable products.
• Scale-up of aseptic drug product processes.
• Proven collaboration with external CDMO partners.
• Developing process development and stability models for formulation performance.
• Strong analytical and problem-solving skills.
• Demonstrated leadership with cross-functional teams.

Responsibilities

• Lead designs of parenteral dosage formulations from pre-clinical to commercial.
• Guide technology transfer and progress fill-finish development at sites.
• Provide leadership to scientists, manage workload and productivity.
• Oversee staff development and participate in talent reviews.
• Drive innovation in subcutaneous and drug-device products.
• Influence regulatory CMC activities and development activities.

Skills

Biologics DP Development

Formulation development

Parenteral dosage forms

Regulatory submissions

CDMO management

Team leadership

Job description

Biogen in Cambridge, MA seeks a Director of Biologics Drug Product Development to lead formulation, fill-finish, and packaging development across the lifecycle. You will guide molecules from pre-clinical to clinical phases toward scalable commercial manufacturing, while shaping new product designs and applying developability and stability models.

You will manage internal scientists and external CDMOs, oversee regulatory submissions, and contribute to department leadership and talent development