Pharmaceutical Serialization Jobs in California (NOW HIRING)

The Opportunity:

Commercial Supplies Packaging Management.

• Serve as the primary technical point of contact for external contract packaging organizations and packaging component suppliers.

• Provide technical support for routine commercial packaging operations at external Contract Manufacturing Organizations (CMOs), including management of deviations, complaints, and investigations related to packaging, labeling, and logistics.

• Drive timely issue resolution to ensure product quality, regulatory compliance, and continuity of supply.

• Partner closely with Quality, Manufacturing, and external partners to ensure uninterrupted commercial supply.

• Support department leadership with resource planning and financial reporting activities.

• Initiate, review and approve internal and CMO specifications for primary, secondary, and tertiary packaging components used for commercial products.

• Author and maintain Bills of Materials (BOMs) and packaging process instructions for new and existing products.

• Collaborate with Technical Development to provide input on manufacturability, scalability, and packaging design for Revolution Medicine products.

• Lead or support technology transfer activities for packaging processes from development to commercial manufacturing.

• Participate in or lead packaging process validation activities for solid dose products across global manufacturing networks.

• Maintain awareness of and ensure compliance with cGMP, regulatory, and internal quality requirements applicable to global pharmaceutical packaging operations.

• Provide all packaging-related support to enable new product launches.

• Support regulatory submissions, inspections, and responses related to packaging and labeling and serialization activities, as needed.

• Ensure all supplies are controlled and distributed in accordance with GMP, GCP, and GDP.

• Develop, maintain and enforce department's business processes and/or SOPs.

• Identify and implement process improvements to increase efficiency, reduce costs, and minimize waste. 

Required Experience, Skills, and Education:

• B.S. or M.S. in, Mechanical or Packaging Engineering, or related field with 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 is a plus.

• 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.

Preferred Skills, Experience and Education:

• Familiarity with pharmaceutical serialization requirements, including DSCSA and EU Falsified Medicines Directive (FMD).

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