Raw Material CTL Lead

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Position: Raw Material CTL Lead

Location: CA,94404

Duration: 8 Months

Job Type: Temporary Assignment

Work Type: Remote

Shift: Mon - Frti 8:00Am - 5:00Pm PST

Job Description:

Responsibilities of the Raw Material CTL Lead include:

• Represent Kite as the Single Point of Contact for all raw material test labs
• Facilitate and effectively communicate information between Kite and external test partners
• Lead resolution of CTL (Contract Test Laboratories) operational issues that impact Kite and collaborate with other Kite 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

TekWissen Group is an equal opportunity employer supporting workforce diversity.