Sr. BioPharma Manufacturing MSAT Process Engineer (Sr. Scientist)

Astellas Pharma • Westborough, MA

50d • $105,280 - $150,400 • Onsite

About The Position

Senior 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.

Requirements

• BS, 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.

Nice To Haves

• Direct 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.

Responsibilities

• Design, 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.

Benefits

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Senior