Director, Downstream Process Development and Manufacturing Biologics

About the role

We're seeking a Director, Downstream Process Development and Manufacturing Biologics to join our Technical Operations CMC team. Reporting to the Executive Director, Pharmaceutical Development, you'll lead the development, scale up, and technology transfer of purification processes for therapeutic proteins, including monoclonal antibodies, antibody-drug conjugates, and microbial derived biologics.

Responsibilities

• 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
• Coach, mentor, and provide 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

Requirements

• PhD with at least 5 years of industry experience or MS with at least 8 years of industry experience
• Deep experience with chromatography systems, filtration, viral inactivation/removal, and CDMO management
• Extensive understanding of cGMP regulations and ICH guidelines
• Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships to strengthen decision-making

Qualifications

• Downstream process development and manufacturing of biologics (e.g., antibodies, ADC, fusion proteins)
• 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 strengthen decision-making

Skills

• Strong leadership and mentoring skills
• Excellent communication and collaboration abilities
• Ability to manage timelines, budgets, and external partnerships
• Knowledge of QbD principles and process validation
• Experience with chromatography systems, filtration, viral inactivation/removal, and CDMO management
• Understanding of cGMP regulations and ICH guidelines

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, an annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP). Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration are also provided. The 401(k) plan includes a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance are offered. Additionally, Insmed provides opportunities for professional development and volunteerism.

Pay

$177,000.00 - $242,000.00 Annual

Schedule

This is a hybrid role based out of our Bridgewater, NJ office. You’ll have the option to work remotely most of the time, with in-person collaboration when it matters most.

Travel

This role requires occasional travel (approximately 10%–20%).