Director, Downstream Process Development and Manufacturing Biologics

Location: Hybrid role based out of the Bridgewater, New Jersey office, with the option to work remotely most of the time and in-person collaboration when needed. Occasional travel of approximately 10%–20% is required.

Salary: $177,000–$242,000 annual.

Company

hirify.global is a global biopharmaceutical company focused on developing treatments that transform the lives of patients with serious and rare diseases.

What you will do

• Provide strategic and technical leadership for downstream process development, scale-up, technology transfer, and manufacturing of therapeutic proteins, including mAbs, ADCs, and microbial-derived biologics.
• Lead end-to-end downstream activities across viral clearance, process characterization, process validation, and BLA-enabling work for clinical and commercial manufacturing.
• Develop phase-appropriate purification strategies covering chromatography, filtration, viral inactivation, and viral filtration.
• Direct process transfers to CMOs and provide technical oversight of CDMO partners through pilot, GMP, and commercial production.
• Author and review technical documentation, including CMC sections, BLA filings, and viral clearance studies.
• Lead and mentor technical teams while managing timelines, budgets, external partnerships, and cross-functional alignment.

Requirements

• PhD with at least 5 years of industry experience, or MS with at least 8 years of industry experience.
• Experience in downstream process development and manufacturing of biologics such as antibodies, ADCs, or fusion proteins.
• Deep expertise in chromatography systems, filtration, viral inactivation and removal, and CDMO management.
• Experience with process characterization and process validation, including Quality by Design principles.
• Extensive knowledge of cGMP regulations and ICH guidelines.
• Ability to collaborate across process development, analytical development, project management, CMC, regulatory, and quality functions.

Nice to have

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

Culture & Benefits

• Medical, dental, vision, and mental health coverage, plus wellbeing reimbursement and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning access, workshops, leadership development, mentoring, and networking opportunities.
• Employee resource groups, service and recognition programs, and opportunities to volunteer and give back.