Sr. Manager, Manufacturing Sciences & Technology

Senior Manager, Manufacturing Sciences & Technology (MS&T)

The Senior Manager, Manufacturing Sciences & Technology (MS&T) serves as the MS&T Product Lead for a commercial small molecule product, leading execution of the manufacturing science strategy across a high-volume, actively evolving commercial program. The product's complicated coating and challenging dissolution profile make process robustness, in-process control, and analytical alignment central to the role. The commercial network produces over 100 batches per year at a single U.S.

-based CDMO partner, with several additional development activities, scale changes, and new manufacturing suites coming online in parallel. This Senior Manager position is responsible for leading execution of PPQ studies for new scales, suites, and process improvements entering the network, and is responsible for the execution and ongoing performance. The Senior Manager serves as the MS&T Subject Matter Expert (SME) for the product and owns manufacturing investigations, change controls, and continuous process verification (CPV) collection and evaluation across a high-throughput commercial program, with particular technical focus on coating uniformity, dissolution performance, and process capability at commercial scale.

The role authors the technical content of regulatory submissions supporting global filings and launch expansion, including NDAs, CBE-30s, annual reports, and international market submissions, and supports production timing and capacity planning with Supply Chain and Commercial Operations to sustain an active, high-volume manufacturing calendar.

• Serve as the MS&T Product Lead for the commercial small molecule product throughout its lifecycle, including its expanding portfolio of scales, suites, and line extensions.
• Serves as MTO lead for all inspection readiness and actual inspection activities for the Company.
• Develop and execute manufacturing science strategies supporting a high-volume commercial program (100+ batches per year), supply continuity, regulatory compliance, and operational excellence.
• Provide advanced technical leadership supporting commercial manufacturing campaigns, parallel scale changes, and new manufacturing suite start‑ups at the CDMO.
• Ensure manufacturing processes remain robust, compliant, validated, and inspection ready, with particular attention to coating uniformity and dissolution performance.
• Drive continuous improvement initiatives focused on process capability, manufacturing reliability, product quality, and operational efficiency across a high‑throughput program.

• Lead process development activities as needed for new scales, suites, or line extensions, including pre‑PPQ technical ownership where a dedicated Process Development lead has not yet been assigned.
• Lead execution of process validation and PPQ studies for new scales and suites, and own the process technically upon PPQ completion.
• Own CPV strategy, execution, and data trending across the commercial program, with emphasis on coating, dissolution‑related process parameters and inspection performance.
• Lead manufacturing investigations, deviations, CAPAs, and change controls, and lead troubleshooting of complex technical issues related to coating, dissolution, and other critical quality attributes.
• Lead implementation of process, scale, equipment, and site changes across parallel initiatives while maintaining validated process performance.

• Partner closely with Process Development to ensure successful transfer of process knowledge and scientific understanding into manufacturing for new scales and suites.
• Responsible for ensuring all process history is properly documented.
• Collaborate with Quality Assurance to ensure manufacturing compliance, deviation management, investigations, CAPAs, and inspection readiness.
• Work closely with Quality Control to ensure analytical and dissolution testing performance supports manufacturing and lifecycle management.
• Partner with Supply Chain to support production timing,…