Process Engineer

Senior BioPharma Manufacturing MSAT Process EngineerSenior Process Engineer, Manufacturing Science & Technology (MS&T) is an experienced technical individual contributor responsible for enabling robust GMP execution, technology transfer, commercial readiness, and lifecycle support for current and future MA-TC manufacturing programs. This role provides data-driven technical leadership across GMP operations, Pre-PPQ and PPQ readiness, process control strategy, material and supply risk assessment, digital/data enablement, and technical capability building. The position works independently and collaboratively with Manufacturing, Process Development, Quality, Validation, QC, Supply Chain, Automation/IT, Regulatory/CMC, and external partners to ensure phase-appropriate process readiness, right-first-time execution, and inspection readiness.Role and ResponsibilitiesDesign, author, and execute laboratory study protocols for human stem-cell-based cell therapy processes, including stem cell culture, differentiation, process characterization, process optimization and/or scale-up, new process/technology evaluation, and troubleshooting studies.Analyze experimental, process, and manufacturing data using appropriate statistical and digital/data tools; interpret results in the context of cell biology, process understanding, CPPs, CQAs, IPCs, raw material attributes, process risks, and control mechanisms.Author clear, scientifically sound technical reports, study summaries, data packages, technical assessments, comparability assessments, process monitoring plans, and recommendations to support GMP robustness, technology transfer, commercial readiness, and future PPQ readiness.Provide timely, data-driven MS&T technical support for GMP manufacturing campaigns, including shop-floor technical readiness, troubleshooting, deviation investigation, root cause analysis, CAPA development, change control input, and campaign summary or technical reports.Lead or significantly contribute to technology transfer and commercial readiness activities, including process fit assessment, facility fit, process description, batch record readiness, engineering and characterization study planning, Pre-PPQ readiness, PPQ protocol input, sampling strategy, acceptance criteria, and execution support.Assess critical raw materials, single-source materials, plastics, consumables, and process-impacting material changes; support mitigation strategies in collaboration with Supply Chain, Quality, Manufacturing, and Process Development.Drive process monitoring, data trending, statistical analysis, and fit-for-purpose digital/data practices to improve process visibility, support continued process verification concepts, enable inspection readiness, and identify opportunities for standardization, automation, productivity improvement, and COGM reduction.Represent MS&T in cross-functional forums and technical discussions; translate technical information into clear recommendations, decision points, and action plans for stakeholders at different technical levels.Support audit and inspection readiness by ensuring technical rationale, GMP documentation, data integrity, process history, and knowledge management records are accurate, retrievable, and scientifically sound.Mentor junior MS&T staff and Manufacturing partners by developing structured technical training, sharing process knowledge, strengthening GMP awareness, and supporting sustainable site technical capability.Proactively identify gaps in process robustness, GMP execution, laboratory study capability, digital capability, and commercial readiness; propose pragmatic, phase-appropriate improvements aligned with MA-TC strategic priorities and approved CMC timelines.Perform other duties and responsibilities as assigned. Responsibilities may evolve based on business needs, organizational priorities, and program requirements.Required QualificationsBS, MS or PhD in Cell Biology, Stem Cell Biology, Developmental Biology, Bioengineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, Engineering, or related discipline with 10+ years of relevant experience for BS, 7+ years for MS, or 3+ years for PhD in cell therapy, regenerative medicine, GMP manufacturing, MS&T, Process Development, Process Engineering, Validation, or related technical operations.Strong cell biological background with hands-on experience in human cell culture, cell-based process development, and/or cell therapy manufacturing support; experience with both small-scale and scale-up cell culture systems is preferred.Demonstrated experience developing study protocols, independently executing laboratory studies, analyzing experimental/process data, and writing technical reports or study summaries that support process understanding and technical decision-making.Direct GMP manufacturing support experience, including deviation investigation, CAPA, change control, batch record review/support, technical writing, and data integrity expectations.Demonstrated ability to analyze process data, identify trends, connect data to technical rationale, and communicate conclusions to technical and non-technical stakeholders.Working knowledge of technology transfer, process risk assessment, process monitoring, GMP documentation, and phase-appropriate technical readiness in biologics, cell therapy, regenerative medicine, or other complex aseptic manufacturing environments.Strong problem-solving, technical judgment, organizational discipline, and ability to independently manage multiple priorities in a fast-paced GMP and laboratory environment.Effective cross-functional communication skills and ability to influence without authority across Manufacturing, PD, QA, QC, Validation, Supply Chain, Automation/IT, and Regulatory/CMC partners.Ability and willingness to mentor junior staff, build technical training content, and contribute to knowledge retention and capability development.Preferred QualificationsDirect experience with regenerative medicine platforms, aseptic cell processing, or complex biologics manufacturing.Experience supporting late-stage clinical or commercial readiness, including Pre-PPQ, PPQ, process validation, continued process verification, process control strategy, or Regulatory/CMC support.Experience designing and executing laboratory studies that bridge Process Development, MS&T, and GMP Manufacturing needs, including process characterization, scale-up, comparability, raw material impact, or troubleshooting studies.Experience with statistical tools and digital/data systems such as JMP, Excel-based data analysis, Power BI, EBR, LIMS, ELN, SAP, or similar systems.Familiarity with ICH Q8, Q9, Q10, Q11, Q12, process validation lifecycle concepts, Quality by Design, control strategy, and inspection readiness expectations.Demonstrated success leading technical workstreams, building new laboratory or digital capabilities, standardizing workflows, and improving operational discipline in a developing organization.Location and Working EnvironmentThis position is based in Westborough, MA and will require on-site work in support of a cGMP regulated manufacturing and laboratory environment.A significant portion of this role is expected to be laboratory-based, including hands-on cell culture/differentiation studies, study execution, sample coordination, data review, and technical documentation.This role may require periodic support outside normal business hours to address critical GMP operations, manufacturing campaigns, deviations, laboratory study timelines, readiness milestones, or urgent business needs.This role may involve extended periods of sitting, standing, computer-based work, document review, laboratory work, and occasional entry into GMP areas in accordance with site procedures.Occasional travel to other Astellas sites or external partners may be required.What awaits you at Astellas?Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.Our Organizational Values and BehaviorsValues: Innovation, Integrity and Impact sit at the heart of what we do.Behaviors: We come together as 'One Astellas', working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.Salary Range$105,280-$150,400 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)Benefits:Medical, Dental and Vision InsuranceGenerous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down401(k) match and annual company contributionCompany paid life insuranceAnnual Corporate Bonus and Quarterly Sales Incentive for eligible positionsLong Term Incentive Plan for eligible positions