MS&T Process Specialist
$73,500–$73,500 year
On-siteWatertown, Massachusetts, United States
Job Summary
Act as the subject matter expert for assigned pharmaceutical manufacturing processes, owning deep process knowledge from clinical through commercial production. Provide front-line technical support to manufacturing, driving process characterization, robustness programs, and continuous inspection readiness. Author investigations for product deviations, apply root cause analysis methodologies, and initiate CAPAs to eliminate recurrence. Support technology transfer activities, equipment qualification, and cross-functional collaboration with CMC, Quality, and site operations. Maintain assigned processes at continuous inspection readiness, including SOPs and qualification documentation, while delivering technical training to manufacturing personnel. This role serves as a critical interface between site operations, Quality, and CMC/Radiochemistry to ensure robust manufacturing outcomes in personalized medicine and radiopharmaceuticals.
Required Qualifications
- Bachelor's degree in Chemical Engineering, Chemistry, Life Sciences, or a related field
- Minimum of 3 years of relevant experience in pharmaceutical manufacturing, MS&T, or a directly related function in a cGMP environment
- Demonstrated expertise in deviation management, root cause analysis, CAPA authorship, and change control
- Working knowledge of GMP regulations including FDA 21 CFR Parts 210 and 211, ICH guidelines, and relevant pharmacopeial standards
- Experience supporting technology transfer activities from development into GMP manufacturing, including CDMO or CMO interfaces
- Proficiency with electronic quality management systems
- Strong technical writing skills and the ability to produce clear, well-structured documentation under time pressure
- Excellent interpersonal and communication skills with demonstrated ability to work effectively across functional boundaries
Desired Qualifications
- Prior experience in radiopharmaceuticals, sterile injectables, or small-volume parenteral manufacturing
- Experience in process development, process engineering, or technical design, including exposure to radiochemistry, CMC activities, or pharmaceutical development workflows
- Experience with Qualio or comparable QMS platforms
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