Director, Downstream Process Development and Manufacturing Biologics

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.

What You'll Do

• 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

Who You Are

You have a PhD along with at least 5 years of industry experience or MS with at least 8 years of industry experience.
You are or you also have:
- 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 have (but not required)

• Degree in Chemical Engineering, Biotechnology or relevant scientific field

Where You’ll Work

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 Requirements

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

Pay Range

$177,000.00-242,000.00 Annual