Director, Upstream PD and Manufacturing (Biologics)

TL;DR

Director, Upstream PD and Manufacturing (Biologics): Drive the design, optimization, and scale-up of upstream processes for therapeutic biologics with an accent on cell line characterization, media/feed strategy, bioreactor operations, and process validation. Focus on overseeing CDMO partners, advancing portfolio from early development to commercial readiness, and establishing control strategies aligned with QbD principles.

Location: Hybrid role based out of Bridgewater, NJ office, option to work remotely most of the time, with in-person collaboration when needed. Occasional domestic and international travel (10-20%).

Salary: $177,000–$242,000 Annual

Company

Global biopharmaceutical company dedicated to transforming lives of patients with serious and rare diseases.

What you will do

• Lead upstream process development and manufacturing strategy for biologics including mAbs and fusion proteins, covering cell line evaluation, media optimization, bioreactor operations, and scale-up.
• Serve as thought leader on biologics manufacturing platforms, implementing innovative technologies like perfusion systems and single-use bioreactors.
• Partner with R&D, Regulatory, Commercial Manufacturing, and Quality teams for alignment from development to commercialization.
• Manage CDMO relationships, program timelines, budgets, deviations, and investigations.
• Develop control strategies, validation approaches, and process characterization studies using QbD principles.
• Author regulatory submissions and act as SME in interactions, audits, and inspections.

Requirements

• PhD + 11 years or BS/MS + 14 years in drug substance development and manufacturing.
• Proven leadership in upstream process development for recombinant proteins including antibodies and fusion proteins.
• Deep expertise in mammalian cell culture technologies and bioreactor platforms (Ambr, benchtop, pilot, commercial).
• Success scaling processes to commercial scale, transferring to GMP facilities, and delivering with CDMOs.
• Experience advancing drug substance from IND to commercialization, process characterization, PPQ, and QbD.
• Extensive cGMP and regulatory knowledge, strong analytical, data interpretation, and communication skills.

Nice to have

• Degree in Chemical Engineering, Biochemical Engineering, or Pharmaceutical Sciences.
• CHO cells experience.
• Continuous or perfusion-based bioprocessing.

Culture & Benefits

• Comprehensive medical, dental, vision, mental health support, wellbeing reimbursement, EAP.
• Generous PTO, fertility/family benefits, caregiver support, flexible schedules.
• 401(k) with match, equity awards, ESPP, company-paid life/disability insurance.
• Learning Institute with LinkedIn Learning, workshops, leadership programs, mentorship.
• Employee resource groups, recognition programs, volunteering opportunities.