Director, Downstream Process Development And Manufacturing Biologics

TL;DR

Director, Downstream Process Development and Manufacturing Biologics (Biotech): Providing strategic and technical leadership for the development, scale-up, and technology transfer of purification processes for therapeutic proteins with an accent on mAbs, ADCs, and microbial-derived biologics. Focus on leading technical teams, managing CDMO partnerships, and ensuring robust, compliant manufacturing processes through QbD principles.

Location: Hybrid role based in Bridgewater, NJ

Salary: $177,000–$242,000

Company

hirify.global is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Lead end-to-end downstream process development activities including viral clearance, process characterization, and validation.
• Direct process transfer to CDMOs and oversee scale-up to pilot and GMP commercial production.
• Define and oversee viral safety strategies and chromatography-based clearance steps.
• Author and review technical documents, including BLA filings and CMC sections.
• Provide technical oversight to CDMO partners to ensure robust and compliant manufacturing.
• Mentor and coach technical teams to support scientific growth and career development.

Requirements

• PhD with 5+ years or MS with 8+ years of industry experience in downstream process development.
• Deep expertise in chromatography, filtration, viral inactivation, and CDMO management.
• Extensive understanding of cGMP regulations and ICH guidelines.
• Proven experience in process characterization and validation.
• Must be able to work in a hybrid capacity from the Bridgewater, NJ office.

Nice to have

• Degree in Chemical Engineering, Biotechnology, or a relevant scientific field.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Flexible work schedules with purposeful in-person collaboration.
• Access to the Company Learning Institute, LinkedIn Learning, and mentorship programs.
• Generous paid time off, fertility benefits, and caregiver support.