Senior MSAT Engineer

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

Purpose And Scope

The Senior MSAT Specialist/Engineer is responsible for providing technical leadership across the lifecycle of biologics and advanced therapy products, ensuring robust, compliant, and scalable manufacturing processes. This role serves as a critical bridge between Process Development, Manufacturing, Quality, and external partners to enable successful technology transfer, process validation, and sustained commercial manufacturing. The Senior MSAT Engineer applies deep process and product knowledge to proactively identify risks, drive process improvements, and support regulatory expectations while ensuring reliable supply. This role is based in Sanford, NC.

Essential Job Responsibilities

• Support and execute technology transfer of upstream, downstream, and/or drug product processes from development into GMP manufacturing, including internal sites and CMOs.
• Own process knowledge throughout the product lifecycle, from early clinical phases through PPQ and commercial operations.
• Provide on-the-floor technical support for GMP manufacturing campaigns, including deviation investigation, root cause analysis, and CAPA development.
• Serve as a subject matter expert for critical process parameters (CPPs), critical quality attributes (CQAs), and process controls.
• Support change management activities, including impact assessments and implementation strategies.
• Lead or support PPQ strategy development, execution, and reporting.
• Support CPV programs through data trending, statistical analysis, and process performance evaluation.
• Ensure validation and lifecycle activities align with regulatory expectations (e.g., FDA, EMA, ICH).
• Identify and implement process improvements to enhance robustness, yield, cost, and manufacturability.
• Apply risk-based tools (e.g., FMEA, QRM per ICH Q9) to assess and mitigate process risks.
• Support introduction of new technologies, platforms, or manufacturing capabilities.
• Contribute to regulatory submissions and respond to health authority questions.
• Act as a technical SME during regulatory inspections and audits.
• Routine trending of process data to enhance process understanding, proactively identify gaps and issues, and implement process improvements.
• Author and review process descriptions, standard operating procedures, technical reports, risk assessments, campaign summary reports, health authority briefing documents, submissions, and responses, tech transfer plans/reports, PPQ protocols/reports, process control strategy, and engineering study protocols/reports.
• Mentor junior MSAT engineers and provide technical guidance across teams.
• Collaborate closely with Process Development, Manufacturing, Automation, Validation, CMC teams, Quality, Supply Chain, and Regulatory Affairs.
  
  

Qualifications

Required:

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biotechnology, or a related scientific discipline required
• 6–10 years of experience in biopharmaceutical manufacturing, process development, MSAT, or technical operations with BS, 4-8 years with MS, 2-6 years with PhD
• Direct experience supporting GMP manufacturing for clinical and/or commercial biologics
• Hands-on experience with technology transfer from development into GMP manufacturing
• Strong understanding of biologics manufacturing processes with expertise in upstream and/or downstream unit operations and ability to support other areas as needed
• Demonstrated experience with process characterization and control strategies, critical quality attributes (CQAs), and critical process parameters (CPPs), deviation investigations, root cause analysis, and CAPA development
• Experience supporting process validation (PPQ) and continued process verification (CPV)
• Solid working knowledge of cGMPs, FDA and EMA expectations, and applicable ICH guidelines
• Experience contributing to regulatory submissions and supporting regulatory inspections or audits
• Familiarity with change management, risk assessments, and quality systems
• Strong technical writing skills, including authoring and reviewing protocols, reports, and lifecycle documentation
• Experience with data analysis, statistical tools, and trending to support process monitoring and decision-making
• Demonstrated ability to lead technical discussions, influence decisions, and manage complex issues without direct authority
• Must be highly self-motivated, with solid communication skills, and demonstrate the ability to work in a fast-paced team environment under challenging timelines and lead other professionals and peers
• Capable of working independently with minimal supervision
• Attention to detail supported by good time management and organizational skills
• Ability to support on-site manufacturing operations, including off-shift or campaign-based support as needed
  
  

Preferred

• Experience in gene therapy and/or monoclonal antibody manufacturing
• Understanding of industry expectations with respect to phase appropriate requirements while advancing products from pre-clinical to commercial state
• Experience with statistical analysis and associated software (e.g., JMP)
• Experience with single-use equipment and systems
  
  

Working Environment

• This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
• As assigned, this position may be required to work during non-traditional work hours to support critical business operations
• This is an on-site role working in a cGMP regulated manufacturing facility with some hybrid flexibility
• On occasion, this role may travel to other Astellas sites and/or vendors (0-5%)
  
  

Salary Range : $103,600 - $148,000 (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 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
  
  

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Category Sanford TC

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans