A Director of Manufacturing oversees management of all areas of manufacturing to produce products and direct activities so that approved products are manufactured on schedule and within quality standards and cost objectives.
The Bioprocessing Product Transfer Project Engineer - Bioprocessing provides technical leadership for complex biologics manufacturing technology transfer programs between Contract Manufacturing Organization (CMOs) and internal manufacturing sites. The role supports sterile injectable biologic drug products by leading engineering activities and providing technical support across process development, transfer, qualification, validation, regulatory support, and commercial manufacturing readiness.
Responsibilities:
Providing technical leadership for complex biologics manufacturing technology transfer programs between Contract Manufacturing Organizations (CMOs) and internal manufacturing sites. Supporting sterile injectable biologic drug products by leading engineering activities and offering technical support across process development, transfer, qualification, validation, regulatory compliance, and commercial manufacturing readiness. Leading end-to-end bioprocess technology transfer activities, including process adaptation, scale-up, equipment qualification, validation, and commercial preparation. Serving as the primary engineering liaison between external manufacturing partners and internal teams such as Technical Operations, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Validation. Collaborating with internal cross-functional teams and external partners to lead technical discussions, resolve issues, communicate project status, risks, and recommendations to leadership, and ensuring successful transfer execution. Conducting engineering gap assessments and technical risk evaluations using structured methodologies like FMEA. Supporting regulatory submissions, Biologics License Application (BLA) supplements, inspection readiness, and technical justifications related to manufacturing transfers. Supporting analytical test method transfer activities, IQ, OQ, PQ, GMP, non-GMP, engineering, and PPQ campaign execution, including reviewing protocols, reports, batch records, and technical documentation to ensure regulatory compliance, quality standards, and project timelines. Managing engineering change strategies, ECOs, and documentation release activities through change control systems. Performing other duties as assigned to support Product Transfer and Technical Operations.
Qualifications:
M.S. or Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, Biotechnology, or Engineering; B.S. considered with relevant industry experience. Minimum 4 years of engineering experience in biotech, biologics, pharmaceuticals, or medical devices. Proven success supporting technology transfer, process engineering, validation, or scale-up in FDA-regulated cGMP environments. Deep understanding of biologics manufacturing, bioprocessing (upstream/downstream), sterile technology, single-use systems, and analytical methods. Familiarity with FDA, EMA, ICH, and GMP requirements, including process validation lifecycle and regulatory submissions. Strong project management, technical writing, communication, and stakeholder engagement skills. Experience working directly with CMOs and external manufacturing partners. Scientific leadership experience in GMP biologics manufacturing.
Pay:
$65.00 - $70.00 per hour
Experience:
bioprocessing: 3 years (Required) FDA regulations: 3 years (Preferred)
