Director, Biologics Drug Product Development

Biogen; 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

About This Role

As the Director of Biologics Drug Product Development, you will spearhead the technical development and optimization of drug products within our Biologics portfolio. Situated within the BioATMP/Biologics DP development team, your responsibilities will encompass the development of formulations, fill-finish processes, and primary packaging for new molecules, guiding them from pre-clinical stages through clinical phases to achieve a scalable and cost-effective commercial manufacturing process. You will also lead the design of new drug products throughout their lifecycle stages. By applying predictive models for molecule developability, process stability, and bio-performance, you will ensure that our biologics remain at the forefront of patient-centric solutions. This role demands strategic vision and cross-functional influence as you oversee direct and matrix reports in internal labs and CDMOs, manage critical regulatory submissions, and join the department leadership team to drive innovation and talent development.

What You'll Do

• 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.

Who You Are

You are a visionary leader with a deep passion for biologics drug development. Your strategic insight and exceptional cross-functional influence allow you to navigate complex challenges and drive innovation. You possess a strong analytical mindset, complemented by excellent communication skills, making you adept at presenting to executive management. Your extensive experience in regulatory engagements and your ability to lead diverse teams position you as a key player in advancing our biologics portfolio.

Required Skills

• 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.

Job Level

Management

Additional Information

The base compensation range for this role is: $188,000.00-$258,500.00. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well‑being; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read onto learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. VEVRAA Federal Contractor. We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state. PDN-a3240d86-2bd9-4ad7-9a14-999f964f0a94