MS&T Senior Manager – Drug Product

General Summary

The Senior Manager, Manufacturing Science & Technology (MS&T) – Drug Product Sterile Manufacturing provides technical leadership and lifecycle support for sterile drug product manufacturing processes across clinical and commercial programs. This role is accountable for process transfer, validation, continued process verification, deviation support, and continuous improvement for aseptic manufacturing, sterile filtration, filling, and associated unit operations.

Thisindividual partnerscross‑functionallywith Manufacturing, Quality, Regulatory, Supply Chain, Engineering, and external CMOs/CDMOs to ensure compliant, robust, and efficient sterile drug product operations throughout the product lifecycle.

Key Duties and Responsibilities

Technical Leadership

• Serve as the MS&T technical lead for sterile drug product manufacturing processes, including formulation and compounding, sterile filtration, aseptic filling, visual inspection, and packaging support as applicable.
• Provide scientific and engineering oversight to ensure process performance, robustness, andan appropriate controlstrategy.
• Lead troubleshooting of manufacturing issues and implement sustainable technical solutions.

Process Transfer &Scale‑Up

• Lead technology transfer activities to internal manufacturing sites and external CMOs/CDMOs.
• Author and review technology transfer documentation, batch records, technical reports, and comparability assessments.
• Supportscale‑upactivities and ensure readiness for engineering, PPQ, and commercial manufacturing campaigns.

Validation & Lifecycle Management

• Lead or oversee process validation strategies, PPQ execution support, and continued process verification activities.
• Support and/or leadhold‑timestudies, mixing and filtration studies, and container closure integrity or compatibility assessments asrequired.
• Ensure sterile drug product processesremainin a validated state throughout the product lifecycle.

Manufacturing Support

• Provideon‑the‑floorand remote MS&T support during manufacturing campaigns.
• Partner with Operations to improve yield, cycle time, batch success rate, and overall operational efficiency.
• Support deviation investigations, OOS/OOT events, CAPAs, and change controls usingdata‑drivenandrisk‑basedapproaches.

Quality & Compliance

• Ensure all activitiescomply withcGMPs, regulatory expectations, and internal quality systems.
• Support regulatory filings and health authority inspections by authoring or reviewing technical sections and responding to questions.
• Collaborate closely with Quality Assurance to assess process impacts related to changes, deviations, and validation outcomes.

Leadership &Cross‑Functional Collaboration

• Manage and develop MS&T scientists and engineers, as applicable.
• Provide mentoring, coaching, and technical guidance across the organization.
• Leadcross‑functionalteams and influence stakeholders across Manufacturing, Quality, Process Development, Regulatory, and Supply Chain.
• Drive a culture of technical rigor, collaboration, and continuous improvement.

Knowledge and Skills

• Deep technicalexpertisein sterile drug product manufacturing and aseptic processing.
• Strongproblem‑solving, root cause analysis, andrisk‑baseddecision‑makingskills.
• Demonstrated experience supporting technology transfer, validation, and commercial manufacturing in a GMP environment.
• Experience with deviation investigations, CAPAs, change controls, and risk assessments.
• Strong leadership, project management, and stakeholder management capabilities.
• Excellent written and verbal communication skills.

Education and Experience

• Bachelor’s degree in Chemical Engineering, Bioengineering, Pharmaceutical Sciences, Chemistry, Microbiology, ora relatedscientific or engineering discipline.
• 8+ years of experience in pharmaceutical or biopharmaceutical manufacturing, withsignificant experiencein sterile drug product manufacturing.
• 3+ years of people management experience or equivalent experience leading complexcross‑functionalinitiatives.
• Advanced degree (MS, PhD, or PharmD) preferred.