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.

#LI-CT1 #LI-Hybrid

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Base Pay Salary Range

$143,000-$178,000 USD

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