Job Posting Title:Sr Associate Outsourced Mfg Requisition Number: 8378
Country: US
State: California
Job Location: Foster City
Functional Area: MANUFACTURING/OPERATIONS
Position Type: Regular
Shift: Days
Specific Responsibilities:
Manages the activities within the Manufacturing Department including the coordination of production schedules at CMOs. Ensures all regulatory requirements are met in the Manufacturing Department. Ensures availability of raw material at contractor sites. Manages transfer of new technology from Process Development to Manufacturing. Initiates and implements departmental quality, business and technical audits of API and raw material manufacturingFacilities. Coordinates communication between CMOs and Gilead functional areas.
Works on moderate and highly complex problems requiring evaluations of multiple factors before resolution can be reached. Exercises judgment within defined practices and policies. Effectively interacts with senior management. Must be able to interface with contract sites to ensure production flows smoothly and that all Gilead requirements are met. Must be able to identify creative solutions to diversified challenges within the regulated environment.
Essential Duties and Job Functions:
-Successfully plan, control, and manage all aspects of contract manufacturing and materials procurement from concept to delivery.
-Communicate constantly with international factories and suppliers regarding scheduling of manufacturing.
-Maintain open communication through out the supply chain with product manufacturing, QA, QC, and suppliers regarding schedules, logistics, costs, etc.
-Report accurate product availability in a timely manner.
-Manage all aspects of subcontract manufacturer relationships, including communicating objectives, monitoring vendor performance, and resolving business issues. Find win/win terms for both client and vendor.
-Create and implement agreements as required with manufacturers to ensure consistency of delivery, quality, cost, etc. Work with manufacturing Engineering staff on cost reductions and process improvements.
-Implement strategies and plans for monitoring and improving the performance of manufacturing partners in the areas of quality, delivery, and cost reduction.
-Other duties as assigned.
Executes and tracks a variety of manufacturing projects in the production of commercial products, clinical active Pharmaceutical ingredients (APIs) and intermediate batches either internally or in coordination with contract manufacturers. Participates in the development of department strategies for obtaining and outsourcing raw materials, intermediates and APIs. Coordinates cross-functional efforts to resolve manufacturing issues in projects. May participate in audits including internal sources, raw material vendors, or contract API manufacturers. May review and approve batch record and processing documentation, including planned or unplanned deviations.
Knowledge, Experience and Skills:
Must have a working understanding and application of Manufacturing principles, concepts, industry practices, and standards. Must be able to provide solutions to routine problems. Must have the ability to recognize deviation from accepted practice. Must be able to apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis. Must be able to exercise judgment within generally well-defined procedures and practices to determine appropriate action. Must be able to recognize and interpret filing submission limits and language and interact with Regulatory functions. Normally receives some instruction on routine work, general instructions on new assignments. Strong verbal, technical writing and interpersonal skills are required. Proven ability to interface with management across many functional areas.
Requires a BS degree and minimum 7 years of relevant experience in the Pharmaceutical industry or chemical field, or a MS degree and minimum 5 years of relevant experience. Strong project management, communication, negotiation and interpersonal skills a must.
