Director, Process Engineer - Parenteral Drug Product Development

Role: Process engineer leader focused on parenteral drug product process development from clinical to commercial manufacturing. Responsibilities include designing and executing complex process studies, developing new modalities and presentations (e.g., co-formulation, high concentration), and leading technology transfer efforts for clinical and manufacturing scale-up. Collaborates with internal teams, external partners, and stakeholders to optimize processes, mitigate risks, and ensure regulatory compliance. Drives innovation in manufacturing technologies and supports regulatory submissions (INDs, NDAs, BLAs). Qualifications: Ph.D. in Chemical, Biomedical, or Pharmaceutical Sciences with at least 7 years industry experience in parenteral process development, including peptides, ADCs, fusion proteins, mAbs, and vaccines. Hands-on experience with large-scale process development, process optimization, and cGMP compliance required. High-value biopharma specifics: expertise in biologics, vaccines, and gene therapies (AAV, mRNA), with experience in process transfer, tech development, and regulatory documentation. Work environment: laboratory setting; physical demands consistent with lab work. Travel not specified but involved in cross-site collaborations.