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…