Director, Downstream Process Development and Manufacturing Biologics
About The Position
At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Director, Downstream Process Development and Manufacturing Biologics on the Technical Operations CMC team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Pharmaceutical Development you’ll provide strategic and technical leadership for the development, scale up and technology transfer of purification processes for therapeutic proteins, including monoclonal antibodies (mAbs), antibody-drug conjugate (ADCs), and microbial derived biologics. You are responsible for leading and mentoring technical teams, while managing timelines, budgets, and external partnerships.
Requirements
- PhD along with at least 5 years of industry experience or MS with at least 8 years of industry experience.
- Downstream process development and manufacturing of biologics (e.g., antibodies, ADC, fusion proteins).
- Deep experience with chromatography systems, filtration, viral inactivation/removal, and CDMO management.
- Experience and knowledge in process characterization and process validation.
- Extensive understanding of cGMP regulations and ICH guidelines.
- Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships to strength decision-making.
Nice To Haves
- Degree in Chemical Engineering, Biotechnology or relevant scientific field.
Responsibilities
- Lead end to end downstream process development activities across all unit operations including viral clearance, process characterization (QbD), process validation and BLA enabling activities to support clinical and commercial manufacturing.
- Develop and implement phase appropriate downstream purification strategies for early/late-stage pipeline projects, ensuring high product purity and quality.
- Direct the development and transfer of processes to Contract Manufacturing Organizations (CMOs) and oversee scale-up to pilot/GMP commercial production.
- Provide technical oversight and direction to CDMO partners to ensure robust, scalable, and compliant manufacturing processes.
- Define and oversee viral safety strategies, including viral inactivation, viral filtration (VF), and chromatography-based clearance steps.
- Supervise the development of filtration (VF, UFDF) and chromatography steps.
- Implement Quality by Design (QbD) principles for process characterization and validation.
- Establish and maintain an understanding of current trends and emerging downstream process technologies to ensure that team is at the forefront of biologics development.
- Author and review technical documents, including BLA filings, CMC sections, and viral clearance studies.
- Provide coaching, mentoring, and technical guidance to support scientific growth and career development.
- Collaborate cross-functionally with internal stakeholders across process development, analytical development, project management, CMC lead, CMC Regulatory and quality departments to align technical strategies with organizational and business objectives.
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support
- Annual wellbeing reimbursement
- Access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- Annual equity awards
- Participation in our Employee Stock Purchase Plan (ESPP)
- Company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups
- Service and recognition programs
- Meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Director
