Senior Manager, Analytical Manufacturing Science and Technology (MSAT)

Position Summary

The Senior Manager, Analytical Manufacturing Science and Technology (MSAT) – is a key member of the MSAT team responsible for managing and supporting analytical activities across contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs) for commercial small molecule products. This role ensures analytical method robustness, compliance, and timely product release while leading technical investigations and supporting method transfers in a fully outsourced environment.

Key Responsibilities

• External Partner Analytical Oversight

• Act as the day-to-day analytical operations lead for assigned small molecule and oral solid commercial products at CMOs and CTLs.
• Ensure contract partners execute analytical testing (release, stability, in-process) in compliance with current Good Manufacturing Practices (cGMP) and company standards - occasional support outside standard business hours may be required to address critical manufacturing or quality events.
• Review and approve test results, stability reports, and method execution documentation from external labs.

• Analytical Method Lifecycle & Technology Transfer Support

• Support analytical method transfer, bridging, and revalidation activities between third-party sites.
• Coverage of analytical method lifecycle, including method transfer, bridging, and revalidation.
• Coordinate and review transfer protocols, reports, and gap assessments with external partners.
• Monitor method performance across sites and batches; lead troubleshooting efforts as needed.

• Investigations & Deviation Resolution

• Oversee analytics-driven risk assessments, trend analysis, and CAPA effectiveness to ensure issues do not repeat.
• Lead or support the resolution of analytical deviations, OOS, OOT, and lab errors at CMOs/CTLs.
• Utilize structured root cause analysis tools (5 Whys, Fishbone diagrams) and Six Sigma problem-solving methodologies (e.g., DMAIC, Pareto analysis) to investigate and resolve issues.
• Drive CAPA development and implementation; ensure timely closure in collaboration with Quality.

• Compliance & Documentation

• Ensure all analytical operations at contract sites meet applicable ICH, FDA, EMA, and global regulatory standards.
• Maintain and review GMP documentation including method validation reports, stability protocols, technical memos, and deviations.
• Participate in audit support and inspection readiness efforts, providing analytical expertise as needed.

• Cross-Functional Collaboration

• Serve as the key point of contact for analytical topics in collaboration with QA, Regulatory CMC, Supply Chain, and Technical Operations.
• Support post-approval changes by coordinating analytical data and contributing to regulatory filings.
• Participate in analytical risk assessments and provide input for change controls affecting commercial methods or testing sites.

Qualifications

• BS/MS/PhD in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• Minimum of 8+ years (BS), 6+ years (MS) of experience in analytical development, QC, or MSAT in a GMP-regulated small molecule environment.
• Strong background in managing analytical activities at CMOs/CTLs for commercial products.
• Technical expertise in chromatographic methods (HPLC/GC), dissolution testing, stability programs, and compendial testing.
• Preferrred Experience: Six Sigma training or certification (Green Belt preferred).
• Hands-on experience with method transfers and managing external lab performance.
• Familiarity with fully outsourced manufacturing models and virtual pharma structures.
• Experience supporting regulatory submissions (e.g., NDA supplements, variations) and inspection readiness.