Job Information
Astellas Pharma Senior MSAT Engineer in Sanford, North Carolina
Senior MSAT Engineer
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose & 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.
Role and 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.
Required Qualifications
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 Qualifications
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
Location and 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 role is based in Sanford, NC.
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%)
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 Behaviors
Values: 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 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