Biologics DP Development Director & Innovation

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

Benefits offered by this job

Medical Insurance

401(k) plan

Stock Purchase Plan

Tuition Reimbursement

Paid time off

Job summary

Biogen in Cambridge, MA is seeking a Director of Biologics Drug Product Development to lead formulation, fill-finish, and primary packaging development from pre-clinical through clinical stages, aiming for scalable, cost-effective manufacturing and a novel drug product design throughout lifecycle.

You will guide cross-functional teams and external CDMOs, manage regulatory submissions, and shape strategy with a focus on developability and product performance, mentoring scientists and driving

Qualifications

• Bachelor’s degree in biopharma with 12+ years in biopharma drug product and combination product development.
• Experience in liquid and lyophilized formulations and commercialization.
• Proven track record with subcutaneous products and external CDMO partners.
• Extensive knowledge of global regulatory requirements for injectable products.

Responsibilities

• Lead design and development of parenteral dosage formulations from pre-clinical to commercial launch.
• Partner with GMTO-led tech transfer teams to progress fill-finish development at internal and external sites.
• Provide leadership to scientists, manage workload, capacity, and productivity, and foster innovation.
• Oversee staff performance, coaching for career development and talent reviews.
• Drive innovation in subcutaneous and drug-device combination products.
• Coordinate regulatory CMC activities and engage with regulatory submissions.

Skills

Biologics Dev

Parenteral Formulation

Regulatory Knowledge

Cross-functional Leadership

Aseptic Scale-up

CDMO Collaboration

Process Modeling

Analytical Skills

Team Leadership

Executive Communication

Education

Bachelor’s degree in Biopharma

Job description

Biogen in Cambridge, MA is seeking a Director of Biologics Drug Product Development to lead formulation, fill-finish, and primary packaging development from pre-clinical through clinical stages, aiming for scalable, cost-effective manufacturing and a novel drug product design throughout lifecycle.

You will guide cross-functional teams and external CDMOs, manage regulatory submissions, and shape strategy with a focus on developability and product performance, mentoring scientists and driving