Sr. MSAT Specialist
Regeneron
5 hours ago
On-site
East Greenbush, NY
Operations
Sr. Manufacturing Sciences & Technology (MSAT) Specialist
Responsibilities:
- Lead assessments of manufacturing requirements/capabilities prior to transfer of new processes; generate facility fit and high-level gap assessments.
- Coordinate creation, management, and maintenance of technology transfer deliverables across the transfer lifecycle.
- Generate and review technology transfer documentation (e.g., master plans/reports, process descriptions, memos, detailed gap assessments).
- Lead projects/initiatives to improve technical support tools for technology transfers.
- Collaborate with managers to assess and adjust technical support activities and functions.
- Perform in-depth reviews of technical documents (e.g., FMEAs, PAR reports, regulatory submissions).
- Lead study teams and investigations during transfers, as applicable.
- Generate options to resolve technical challenges and present for endorsement.
- Provide on-site technical support and training to manufacturing personnel (e.g., synthesis, purification, related operations).
- Capture, trend, and analyze process-generated data; summarize in memos, reports, presentations.
- Review receiving-unit manufacturing documentation (e.g., manufacturing records, batch sheets, changeover protocols, SOPs).
- Build process knowledge base; support knowledge management/lessons learned; identify continuous improvement activities.
Qualifications:
- BS/BA in Life Sciences or Engineering; PhD preferred; 5+ years of relevant experience.
- Preferred: experience with small molecule, oligonucleotide, peptide manufacturing process development or process engineering.
Required/Preferred Skills/Experience:
- Experience interacting with Contract Manufacturing Organizations.
- Ability to work in a team-oriented environment; continuous process improvement mindset.
- Mentoring capability for lower-level specialists.
- Willingness to travel 10–15% annually.
Work Schedule:
- Monday–Friday, 8am–4:30pm.
Application:
- Apply now.
Responsibilities:
- Lead assessments of manufacturing requirements/capabilities prior to transfer of new processes; generate facility fit and high-level gap assessments.
- Coordinate creation, management, and maintenance of technology transfer deliverables across the transfer lifecycle.
- Generate and review technology transfer documentation (e.g., master plans/reports, process descriptions, memos, detailed gap assessments).
- Lead projects/initiatives to improve technical support tools for technology transfers.
- Collaborate with managers to assess and adjust technical support activities and functions.
- Perform in-depth reviews of technical documents (e.g., FMEAs, PAR reports, regulatory submissions).
- Lead study teams and investigations during transfers, as applicable.
- Generate options to resolve technical challenges and present for endorsement.
- Provide on-site technical support and training to manufacturing personnel (e.g., synthesis, purification, related operations).
- Capture, trend, and analyze process-generated data; summarize in memos, reports, presentations.
- Review receiving-unit manufacturing documentation (e.g., manufacturing records, batch sheets, changeover protocols, SOPs).
- Build process knowledge base; support knowledge management/lessons learned; identify continuous improvement activities.
Qualifications:
- BS/BA in Life Sciences or Engineering; PhD preferred; 5+ years of relevant experience.
- Preferred: experience with small molecule, oligonucleotide, peptide manufacturing process development or process engineering.
Required/Preferred Skills/Experience:
- Experience interacting with Contract Manufacturing Organizations.
- Ability to work in a team-oriented environment; continuous process improvement mindset.
- Mentoring capability for lower-level specialists.
- Willingness to travel 10–15% annually.
Work Schedule:
- Monday–Friday, 8am–4:30pm.
Application:
- Apply now.