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Manager, Supply Chain - Global External Testing - Santa Monica California
Company: Gilead Sciences, Inc.
Location: Santa Monica, California
Posted On: 06/14/2024
Manager, Supply Chain - Global External Testing Manager, Supply Chain - Global External Testing United States - California - Santa Monica Manufacturing Operations & Supply Chain Regular Job DescriptionAt 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
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a line between that purpose and our day-to-day work. Would you like to join us in this mission? We are seeking a highly motivated individual to join us as a Contract Test Lab SPOC (Single Point of Contact) to support Kite's global network of Contract Testing Labs ("CTL") within the External Supply and Partnerships team embedded within the Global Supply Chain Organization. The individual will report to the Director, External Supply and Partnerships at Kite.This role will have opportunities to work with and collaborate with different functions and partners across Kite's Technical Operations organization (e.g., Quality Control, Analytical Development, Quality Assurance, Regulatory, Manufacturing, and Supply Chain), as well as key CTL Partners. The ideal candidate will have excellent organization and communication skills, technical knowledge (biologics/gene and cell therapy and raw material testing operations, GMP regulation and drug development life cycle), and network-based thinking (tact, contract negotiation, project management).Responsibilities:Responsibilities of the Commercial Program CTL SPOC include: - Represent Kite as the Single Point of Contact for external testing of vector used to support commercial programs
- Lead intake for new scopes of work supporting commercial programs or site start up: Gather requirements from end users, request quotes from CTLs, initiate sourcing request and review of statements of work documents, and request GMP POs
- Lead focused factory team for external testing of vector
- Facilitate and effectively communicate information between Kite and external test partners
- Lead resolution of CTL operational issues that impact Kite and collaborate with other Kite functions to resolve other quality or technical issues
- Track and communicate sample testing status and delays to internal stakeholders and key team members teams
- Obtain CoA release dates from contract test labs and update internal trackers
- Initiate external deviations (and internal deviations and CAPAs as needed) related to external vector testing, and notify stakeholders
- Distribute monthly sample forecast to CTL partner
- Approve CTL invoices and manage PO spend for each program or study
- Be the first point of contact for CTL invoice resolution and ensure resolution of invoice inquiries
- Gather operational metrics and content in support of internal and external metric review meetingsBasic Qualifications:
- Master 's Degree, contract testing experience and 4+ years of experience in GMP or similar OR
- Bachelor's Degree, contract testing experience and 6+ years of experience in GMP or similar OR
- High School Diploma, contract testing experience and 11+ years of experience in GMP or similarPreferred Qualifications:
- Demonstrates knowledge of Good Manufacturing Practices (GMPs)
- Demonstrates experience working with contract test laboratories or other external contract organizations
- Demonstrates working knowledge of collaboration within a matrix environment
- Demonstrates diplomacy skills and ability to proactively identify and mitigate risks
- Demonstrates outstanding organizational skills with the ability to multi-task and prioritize
- Demonstrates excellent analytical and problem-solving skills and thorough data analytics skills e.g., Tableau, Excel
- Demonstrates excellent oral and written communication skills
- Demonstrates discipline in planning and plan implementation
- Quick learner of new technology/process/work environment and ability to translate learning to work plans for improving business performance
- Patient centric mindset
- Excellent work ethic and a thorough personal desire for successDoes this sound like you? If so, please apply today!#LI-ML1#IND123The salary range for this position is: $121,125.00 - $156,750.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. Job DescriptionAt 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
Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a line between that purpose and our day-to-day work. Would you like to join us in this mission? We are seeking a highly motivated individual to join us as a Contract Test Lab SPOC (Single Point of Contact) to support Kite's global network of Contract Testing Labs ("CTL") within the External Supply and Partnerships team embedded within the Global Supply Chain Organization. The individual will report to the Director, External Supply and Partnerships at Kite.This role will have opportunities to work with and collaborate with different functions and partners across Kite's Technical Operations organization (e.g., Quality Control, Analytical Development, Quality Assurance, Regulatory, Manufacturing, and Supply Chain), as well as key CTL Partners. The ideal candidate will have excellent organization and communication skills, technical knowledge (biologics/gene and cell therapy and raw material testing operations, GMP regulation and drug development life cycle), and network-based thinking (tact, contract negotiation, project management).Responsibilities:Responsibilities of the Commercial Program CTL SPOC include: - Represent Kite as the Single Point of Contact for external testing of vector used to support commercial programs
- Lead intake for new scopes of work supporting commercial programs or site start up: Gather requirements from end users, request quotes from CTLs, initiate sourcing request and review of statements of work documents, and request GMP POs
- Lead focused factory team for external testing of vector
- Facilitate and effectively communicate information between Kite and external test partners
- Lead resolution of CTL operational issues that impact Kite and collaborate with other Kite functions to resolve other quality or technical issues
- Track and communicate sample testing status and delays to internal stakeholders and key team members teams
- Obtain CoA release dates from contract test labs and update internal trackers
- Initiate external deviations (and internal deviations and CAPAs as needed) related to external vector testing, and notify stakeholders
- Distribute monthly sample forecast to CTL partner
- Approve CTL invoices and manage PO spend for each program or study
- Be the first point of contact for CTL invoice resolution and ensure resolution of invoice inquiries
- Gather operational metrics and content in support of internal and external metric review meetingsBasic Qualifications:
- Master 's Degree, contract testing experience and 4+ years of experience in GMP or similar OR
- Bachelor's Degree, contract testing experience and 6+ years of experience in GMP or similar OR
- High School Diploma, contract testing experience and 11+ years of experience in GMP or similarPreferred Qualifications:
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