Senior Manager, Manufacturing

Responsibilities:

• Lead and manage external GMP drug substance manufacturing activities for late phase small molecule API programs
• Oversee manufacture and supply of regulatory starting materials and key intermediates under non-GMP conditions, as applicable, to support late-phase API manufacturing programs
• Manage external partners involved in non-GMP starting material manufacture, including review of manufacturing plans, process descriptions, batch documentation, quality expectations, timelines, and supply readiness
• Partner with Process Chemistry, Quality, Regulatory, and Supply Chain teams to ensure appropriate control, documentation, qualification, and change management for starting materials used in GMP API manufacture
• Assess risks associated with starting material sourcing and manufacture, including supplier reliability, process consistency, impurity profile, traceability, and potential impact on downstream GMP API manufacturing
• Support supplier qualification, technical assessments, and lifecycle management activities for starting materials and key raw materials manufactured under non-GMP conditions
• Oversee technology transfer, scale-up, process optimization, engineering batches, PPQ readiness, and commercial launch preparation
• Serve as the primary technical and operational interface with CMOs for API manufacturing campaigns
• Review and approve batch records, campaign protocols, manufacturing instructions, process validation protocols, and manufacturing reports
• Support process validation strategy, including PPQ planning, continued process verification, and process performance monitoring
• Lead or support deviation investigations, OOS/OOT assessments, root cause analysis, CAPA development, and manufacturing risk assessments
• Ensure manufacturing activities are executed in compliance with cGMP, ICH Q7, ICH Q11, regulatory commitments, and internal quality requirements
• Partner with Process Chemistry and Analytical teams to ensure robust process understanding, impurity control strategy, and process control strategy
• Support preparation and review of CMC regulatory sections for IND, NDA, MAA, Type II variations, supplements, and health authority responses
• Review and assess proposed changes related to raw materials, starting materials, suppliers, process parameters, equipment, manufacturing sites, and analytical methods
• Manage CMO performance, manufacturing timelines, issue escalation, and cross-functional alignment on project deliverables
• Support supplier qualification, raw material strategy, manufacturing readiness, and lifecycle management activities
• Contribute to continuous improvement initiatives to enhance process robustness, manufacturing efficiency, and supply reliability

Preferred Skills, Qualifications and Technical Proficiencies:

• Direct experience supporting NDA, MAA, or commercial launch readiness for small molecule APIs
• Experience with post-approval changes, process validation lifecycle, continued process verification, and regulatory inspection support
• Familiarity with quality risk management principles and impurity control strategies, including genotoxic impurities and nitrosamine risk assessments
• Experience supporting supplier qualification, raw material change assessments, and CMO audits
• Prior experience in outsourced development/manufacturing models
• Strong technical judgment and problem-solving skills
• Ability to lead through influence in a cross-functional matrix environment
• High attention to detail and commitment to GMP compliance
• Effective communication with internal stakeholders and external manufacturing partners
• Strong ownership, accountability, and ability to drive deliverables to completion

Preferred Education and Experience:

• Master’s or Ph.D. degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline. Relevant experience of 8+ years with a Master’s degree, or 5+ years with a Ph.D required
• Strong experience in small molecule API manufacturing, preferably supporting late phase clinical, validation, or commercial programs
• Demonstrated experience working with CMOs and managing external manufacturing campaigns
• Experience managing non-GMP manufacture of regulatory starting materials, advanced intermediates, or key raw materials used in small molecule API manufacturing
• Familiarity with expectations for starting material justification, supplier qualification, impurity control, traceability, and change control in late-phase or commercial API programs
• Solid understanding of cGMP requirements, ICH Q7, ICH Q11, process validation, and regulatory expectations for API manufacturing
• Experience with process transfer, scale-up, PPQ preparation, deviation investigations, CAPAs, and change controls
• Strong technical understanding of synthetic organic chemistry, impurity control, process parameters, in-process controls, and manufacturing documentation
• Experience contributing to CMC regulatory submissions and health authority responses is preferred
• Excellent project management, communication, technical writing, and cross-functional collaboration skills