Sr. MSAT Specialist

Role: Sr. Manufacturing Sciences & Technology (MSAT) Specialist (Process Sciences Drug Product Engineering)

Responsibilities:
- Lead assessments of manufacturing requirements/capabilities prior to technology transfer; generate facility fit and high-level gap assessments
- Coordinate creation, management, and maintenance of transfer activities across the lifecycle
- Generate and review technology transfer documentation (e.g., master plans/reports, process descriptions, memos, detailed gap assessments)
- Lead projects to improve technical support tools for technology transfers
- Collaborate with managers to continuously assess and adjust technical support activities
- Perform in-depth reviews of technical documents (e.g., FMEAs, PAR reports, regulatory submissions)
- Lead study teams and investigations during transfers, as applicable
- Generate and present options to resolve technical challenges
- Provide on-site technical support and training to manufacturing personnel across sites (synthesis, purification, related operations)
- Capture, trend, and analyze process-generated data; summarize in memos, reports, and presentations
- Review receiving-unit manufacturing documentation (manufacturing records, batch sheets, changeover protocols, SOPs)
- Build process knowledge base/controls, knowledge management and lessons learned; identify continuous improvement activities

Qualifications:
- BS/BA in Life Sciences or Engineering; PhD preferred
- 5+ years of relevant experience
- Preferred experience in small molecule, oligonucleotide, peptide manufacturing process development or process engineering
- Team-oriented; experience interacting with Contract Manufacturing Organizations
- Willing to travel 10–15% annually
- Can mentor lower-level specialists

Work schedule: Monday–Friday, 8am–4:30pm

Application: Apply now.