Senior Manager, Clinical Supply Chain
$164,000–$205,000 year
HybridRedwood City, California, United States
Job Summary
Serve as the primary technical point of contact for external contract packaging organizations and suppliers, providing support for routine commercial operations at CMOs including management of deviations, complaints, and investigations. Initiate, review, and approve specifications for primary, secondary, and tertiary packaging components while authoring Bills of Materials and process instructions. Lead technology transfer activities and packaging process validation for solid dose products across global networks, ensuring compliance with cGMP, regulatory, and internal quality requirements. Collaborate with Quality, Manufacturing, and external partners to drive timely issue resolution and ensure uninterrupted commercial supply, while supporting new product launches and regulatory submissions related to serialization. Support department leadership with resource planning and financial reporting, and develop business processes to improve efficiency and reduce costs.
Required Qualifications
- B.S. or M.S. in, Mechanical or Packaging Engineering, or related field
- 8+ years of experience in pharmaceutical logistics and inventory management
- Strong knowledge of cGMPs, pharmaceutical manufacturing principles, and global packaging standards
- Technical proficiency, independent thinking, teamwork and collaboration, including driving continuous improvement
- Demonstrated experience with primary, secondary and tertiary packaging for solid dose products
- Experience supporting new product introductions, technology transfers, and commercial launches in major global markets
- Proven experience working with and managing external contract packaging organizations
- Experience managing complex, cross functional projects across multiple regions and time zones
- Knowledge of distribution and cold chain shipping requirements for pharmaceutical products
- Experience with shipping qualifications and transportation studies
- Financial acumen related to budgeting, forecasting, and cost optimization
- Working knowledge of statistical methods and software to support packaging process optimization and troubleshooting
- Working knowledge of pharmaceutical commercial manufacturing, regulatory, and quality assurance
- Solid project management, facilitation, and problem-solving skills
- Solid organizational and time management skills
- Strong communicator and connector between Commercial, Finance, Quality, Regulatory and Supply Chain teams
- Effective, open, and transparent communication skills (verbal and written)
- Capable of working on multiple projects/tasks and able to meet timelines
- Self-starter with a high level of comfort with ambiguity and complexity and the ability to multi-task while consistently delivering quality results
- A team-oriented, progressive thinker who enjoys participating in an innovative and creative work environment
- Must be available for onsite work at headquarters in Redwood City, CA
Desired Qualifications
- Familiarity with pharmaceutical serialization requirements, including DSCSA and EU Falsified Medicines Directive (FMD)
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