Manufacturing Team Lead

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
 

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Manufacturing Team Lead

Role and Responsibilities:

· Manages a team or shift of personnel and serves as a mentor to junior staff.

· Has an ability to communicate clearly and effectively with peers within the organization.

· Leads special team projects within the manufacturing unit/function.

· Serves as a representative on cross-functional projects to support more senior colleagues in the function.

· Exercises diplomacy and critical thinking skills while troubleshooting issues with internal and external groups.

· Clearly and concisely explains process/product features, performance, and deviations to multiple audiences.

· Manages the storage, replenishment, usage, and discarding of hazardous and volatile chemicals.

· Performs a daily thorough check of the equipment and clean room areas and follows through with service requests to for maintenance/automation/facilities teams to correct identified issues.

Essential Duties and Job Functions:

· Attends mandatory company training and ensures he/she is trained on production processes.

· Provides hands on guidance to Manufacturing technicians.

· Conducts technicians’ performance evaluations, one on one meetings, and quarterly check ins.

· Expedites production scheduling through communication with QA/QC and Inventory Control personnel.

· Delegates and oversees corrective maintenance work orders for clean room equipment and rooms.

· Establishes and maintains 6S housekeeping standards for manufacturing owned areas.

· Maintains an accurate inventory of product components within L10 storage locations.

· Supervises personnel, including organizing and prioritizing daily tasks, performing/scheduling training, writing performance reviews.

· Works on complex issues where analysis requires an in-depth assessment, considering many variables, and potential consequences.

· Uses advanced statistical techniques to complete projects.

· Uses more complex research techniques and methodologies like Six Sigma and Kaizen to improve process/product quality.

· Demonstrates proficiency in regulatory affairs and applies knowledge to processes.

· Writes and/or implements changes to controlled documents (e.g., SOP’s, Specifications, Methods, etc.) as needed.

· Exercises judgment within well defined and established procedures and practices to determine appropriate action with minimal supervision.

· Develops solutions to moderately complex problems and conducts final reviews of logbooks and production records prior to batch release.

Knowledge, Experience and Skills:

· Demonstrates strong knowledge of Good Manufacturing Practices (GMPs) and working knowledge of regulatory filing requirements and guidance documents (i.e. SUPAC, PACPAC).

· Is able to provide solutions to moderately complex to semi-routine problems.

· Demonstrates excellent verbal, written, and interpersonal communication skills.

· Demonstrates strong computer, organizational, and project management skills.

· Demonstrates ability to recognize deviation from accepted practice.

· Demonstrates ability to apply knowledge of current Good Manufacturing Practices (cGMPs) daily.

· Demonstrates ability to successfully supervise and support junior staff.

Basic Qualifications:

· At least 6 years of relevant experience and a BS or BA.

· At least 4 years of relevant experience and a MS.

· Prior experience in a cGMP related industry is required, within Biopharmaceutical or Pharmaceutical industry preferred.

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