The Opportunity:

Oversee technical transfers, qualification activities, product lifecycle management and routine commercial manufacturing for assigned commercial products and CMO sites; including drug-product operations involving spray-dried dispersions (SDD), granulation, blending, milling, compression/encapsulation, film coating, and related solid oral dose manufacturing unit operations. This includes transfer planning and execution; process, equipment, and site readiness assessments; qualification and validation strategy; ongoing performance monitoring; and implementation of post-approval changes, process improvements, and supply-continuity initiatives throughout the product lifecycle.

The successful candidate will serve as the technical person for assigned CMOs, partnering cross-functionally with Quality, Supply Chain, Regulatory, and external partners to manage performance, investigate issues, drive continuous improvement, and maintain a state of inspection readiness. This role requires the ability to provide technical oversight of complex commercial drug-product processes in specialized particle-engineering and solid-dose operations.

• Serve as the primary technical person for assigned commercial CMOs, providing day-to-day oversight of manufacturing operations, technical performance, and compliance, with particular focus on SDD, granulation, coating, and other critical drug-product unit operations, as applicable.

• Assess CMO site capability, capacity, facility fit, manufacturing infrastructure, utilities, and readiness to support commercial demand and future product needs.

• Evaluate and define requirements for manufacturing processes, process equipment, automation, process controls, and other site-specific technical needs.

• Manage manufacturing technical transfers, including transfer planning, site readiness, process implementation, execution support, and post-transfer monitoring.

• Manage equipment and process qualification, validation, PPQ, and continued process verification (CPV) activities.

• Manage manufacturing lifecycle activities, including post-approval changes, process improvements, scale or capacity changes, technical risk mitigation, and supply-continuity initiatives.

• Manage manufacturing-related deviations, complaints, nonconformances, investigations, root-cause analyses, CAPAs, and change controls.

• Partner with Quality, Supply Chain, Regulatory, and CMO teams to maintain cGMP compliance, drive continuous improvement, manage documentation including change controls, and prepare for audits and inspections.

• Support APQRs by authoring appropriate manufacturing sections.

Required Skills, Experience and Education:

• Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, Chemistry, or a closely related technical discipline.

• Approximately 6–8 years of relevant pharmaceutical or biotechnology industry experience.

• Demonstrated commercial drug-product manufacturing experience, including technical operations, manufacturing science, process engineering, or manufacturing support.

• Experience managing or providing technical oversight to external CMOs or contract manufacturing sites.

• Strong knowledge of commercial drug-product manufacturing, process and equipment qualification, process validation (PPQ), and Continuous Process Verification (CPV).

• Working knowledge of cGMP requirements and quality systems, including deviations, CAPA, complaints, change control, and technical documentation.

• Demonstrated ability to assess manufacturing-site capability, capacity, process fit, equipment needs, and operational risks.

• Strong communication, technical writing, project-management, and cross-functional collaboration skills; willingness to travel to CMO sites as needed.

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