Director, Downstream Process Development and Manufacturing Biologics

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

Company

hirify.global is a global biopharmaceutical company developing medicines for patients with serious and rare diseases.

What you will do

• Lead end-to-end downstream process development for early- and late-stage biologics programs, including antibodies, ADCs, and fusion proteins.
• Develop and implement purification strategies covering chromatography, filtration, ultrafiltration/diafiltration, viral inactivation, and viral filtration.
• Direct process transfer to contract manufacturing organizations and oversee scale-up through pilot and GMP commercial production.
• Provide technical oversight of CDMO partners and ensure robust, scalable, compliant manufacturing processes.
• Apply Quality by Design principles to process characterization and validation, and define viral safety strategies.
• Prepare and review BLA filings, CMC sections, viral clearance studies, and other technical documentation while mentoring scientific staff and collaborating with process development, analytical, CMC, regulatory, quality, and project management teams.

Requirements

• PhD with at least 5 years of industry experience, or MS with at least 8 years of industry experience.
• Degree in Chemical Engineering, Biotechnology, or a related scientific field.
• Deep experience in downstream process development and manufacturing of biologics.
• Extensive experience with chromatography systems, filtration, viral inactivation/removal, process characterization, process validation, and CDMO management.
• Strong understanding of cGMP regulations and ICH guidelines.
• Willingness to collaborate across functions, incorporate diverse perspectives, and manage stakeholder relationships effectively.

Culture & Benefits

• Hybrid work model with flexible schedules and purposeful in-person collaboration.
• Medical, dental, vision, and mental health coverage, plus an annual wellbeing reimbursement and Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, and caregiver support.
• 401(k) plan with company match, annual equity awards, employee stock purchase plan, and company-paid life and disability insurance.
• Learning and development through LinkedIn Learning, workshops, leadership programs, mentorship, networking, and employee resource groups.