We are seeking an experienced Senior Manager, Drug Substance Manufacturing to support late-stage development and commercial readiness activities for small molecule active pharmaceutical ingredients (APIs) , including oversight of GMP API manufacturing and non-GMP starting material manufacturing activities. This role will be responsible for managing external manufacturing activities at contract manufacturing organizations (CMOs), supporting process validation and regulatory submission readiness, and ensuring robust execution of GMP manufacturing campaigns for late phase and commercial API programs as well as reliable supply of starting materials manufactured under non-GMP conditions.

The successful candidate will provide technical and operational leadership for drug substance manufacturing, process transfer, process validation, deviation investigation, change control, and continuous improvement activities. This position requires strong experience in small molecule API manufacturing, late-stage CMC development, GMP operations, and cross-functional collaboration with Quality, Regulatory, Supply Chain, Process Chemistry, Analytical Development, and external partners.

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

The pay range that the Company reasonably expects to pay for this headquarters-based position is $173,430 - $204,030; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education.

Applicants must be currently authorized to work in the United States on a full-time basis.

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