Senior Process Development Engineer - Upstream

SummaryIn biologics process development, the Senior Process Development Engineer – Upstream works within a highly cross-functional team to advance our products from early to late-stage development. Responsibilities span upstream microbial activities from seed train through primary recovery with a focus on late-stage development.Essential Duties and ResponsibilitiesProcess DevelopmentDesign, execute, and optimize upstream microbial (E. coli, P. pastoris, B. subtilis) unit operations (e.g. seed train, production fermentation; centrifugation, cell lysis and depth filtration) to deliver scalable, high‑yield, high‑purity processes that meet target CQAs.Process Transfer, Validation, and Technical SupportProvide on-site and remote support for manufacturing processes, addressing technical issues that arise during production.Review and approve GMP documentation, support investigations by applying rigorous scientific principles and data analysis to solve complex process challenges.Lead process changes and new process transfers from development to manufacturing; act as liaison between PD and ManufacturingCross‑Functional Collaboration & Program SupportServe as the USP representative on CMC teams; integrate with Downstream, Analytical Development, Formulation, Quality, and Regulatory to align development plans, timelines, and deliverables.Prepare and deliver technical presentations and updates to project leadership, governance, and external partners/CMOs.Education or Degree RequirementsA Bachelor’s degree in an engineering discipline is required. Equivalent experience may be considered.Professional Experience Requirements and Qualifications8+ years of industry experience is required, including a minimum of 5 years work experience in a GMP, development, operational or manufacturing environment. Post-doctoral work may serve as experience.Demonstrated expertise in seed train and production fermentation, centrifugation, cell lysis and depth filtration from lab to pilot scale.Hands‑on with Sartorius systems and control software (e.g., DeltaV/ABB); proficiency in stainless steel fermentor and continuous flow centrifugation operations.Familiarity with cGMP expectations for clinical manufacturing and authoring/review of cGMP‑aligned documentation.Experience collaborating with Manufacturing, supporting engineering/clinical runs, and executing process transfers.Strong cross‑functional communication and stakeholder management in a matrixed environment; ability to present complex data clearly to technical and non‑technical audiences.Must possess excellent oral and written communication skills.Results oriented, organized, and thorough, with high standards for data integrity and safety.Additional RequirementsMay require up to 50% domestic and international travel to contract manufacturing sites or business partners.