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. 

This individual partners cross‑functionally with 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, and an appropriate control strategy. 

• 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. 

• Support scale‑up activities 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 lead hold‑time studies, mixing and filtration studies, and container closure integrity or compatibility assessments as required. 

• Ensure sterile drug product processes remain in a validated state throughout the product lifecycle. 

Manufacturing Support 

• Provide on‑the‑floor and 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 using data‑driven and risk‑based approaches. 

Quality & Compliance 

• Ensure all activities comply with cGMPs, 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. 

• Lead cross‑functional teams 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 technical expertise in sterile drug product manufacturing and aseptic processing. 

• Strong problem‑solving, root cause analysis, and risk‑based decision‑making skills. 

• 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, or a related scientific or engineering discipline. 

• 8+ years of experience in pharmaceutical or biopharmaceutical manufacturing, with significant experience in sterile drug product manufacturing. 

• 3+ years of people management experience or equivalent experience leading complex cross‑functional initiatives. 

• Advanced degree (MS, PhD, or PharmD) preferred.