Raw Material CTL Lead

VARITE is looking for qualified Raw Material CTL Lead (Remote)
 
WHAT THE CLIENT DOES?
An American biotechnology company that develops cancer immunotherapy products with a primary focus on genetically engineered autologous CAR T cell therapy - a cell-based therapy which relies on chimeric antigen receptors and T cells.
 
WHAT WE DO?
Established in the Year 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.
 
Job Title: Raw Material CTL Lead
Location: Foster City, CA (Remote)
Contract Duration: 8 months with possible extension
Pay Range: $50.00/hr. to $55.56/hr. on W2
Work Authorization: US Citizen or Green Card only
 
HERE’S WHAT YOU’LL DO
Responsibilities of the Raw Material CTL Lead include:

• Represent **** as the Single Point of Contact for all raw material test labs
• Facilitate and effectively communicate information between **** and external test partners
• Lead resolution of CTL (Contract Test Laboratories) operational issues that impact **** and collaborate with other **** functions to resolve other quality or technical issues
• Track and communicate raw material sample testing status and delays to internal stakeholders and leadership teams
• Obtain CoA release dates from contract test labs and weekly reports, and update internal trackers
• Triage SCARs (and deviations and CAPAs as needed) related to raw material test labs and notify stakeholders
• Create and distribute monthly raw material testing forecast to CTLs
• Track accuracy of raw material test forecast and work with data analytics to resolve discrepancies
• Update forecast data sheet monthly with updated and new raw material specifications
• Approves CTL invoices and manages PO spend for each test lab
• Be the first point of contact for CTL invoice resolution and ensure resolution of CTL invoice inquiries
• Lead intake for new scopes of work for raw material test labs: Gather requirements from end users, request quotes from CTLs, initiate sourcing request for SOWs, and create and own GMP POs
• Gather operational metrics and content for business review meeting with CTLs
• Support ES&P QMR with raw material test lab metrics (as requested)

 
Education Level:

• Master's Degree, contract testing experience and 3+ years of experience in GMP or similar OR
• Bachelor's Degree, contract testing experience and 5+ years of experience in GMP or similar OR
• Associate's Degree, contract testing experience and 7+ years of experience in GMP or similar
• High School Degree, contract testing experience and 10+ years of experience in GMP or similar

 
Experience:

• 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 strong analytical and problem-solving skills and strong data analytics skills e.g. Tableau, Excel
• Demonstrates excellent oral and written communication skills
• Demonstrates discipline in planning and plan execution
• Quick learner of new technology/process/work environment and ability to translate learning to work plans for improving business performance
• Patient centric mindset
• Superior work ethic and a strong personal desire for success

 
BENEFITS:
We offer a comprehensive benefits package designed to support the health, well-being, and financial security of our employees and their families. Eligible employees may receive:

• Health Insurance: Medical, dental, and vision coverage
• Retirement Plans: Participation in a company-sponsored retirement savings plan.
• Legal Service Plans: Offering access to attorneys for legal advice and representation.

 
If this opportunity interests you, please respond by clicking on EasyApply.
 
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VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.