Hiring company: Kite Pharma
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.
Kite is seeking a highly motivated individual to join our team as Director, Quality Control to be the Technical Lead for Kite’s global network of Contract Testing Labs (CTLs). This role will report to the Senior Director, External Quality. Key responsibilities include overseeing all the Quality aspects for external testing operations and acting as the point of contact for technical issues.
Responsibilities:
- Serves as the Quality Technical lead for Kite’s Contract Testing Labs (CTLs).
- Provides technical support for OOS investigations around laboratory issues or failures. Develops/recommends corrective actions.
- Accountable for resolution of major/critical technical issues or trends of invalid assays related to the analytical testing at CTLs. Escalate issues as needed/required.
- Provides information on technical issues, including resolution for operational review meetings and in support of supplier performance scorecards.
- Manages analytical method transfer and phase appropriate qualification/validation of analytical methods from Analytical Development or QC to the Contract Testing Lab. Ensures methods are robust prior to transfer.
- Reviews proposed changes to systems, procedures, methods, and submissions to regulatory agencies as appropriate.
- Generates CoAs (Certificate of Analysis) for in-process material (e.g. viral vector) and final product for product disposition.
- Collaborates and maintains routine interactions with Global QC and Analytical Development.
- Supports identification, selection, and qualification and on-boarding of CTLs.
- Supports review of contracts and agreements to ensure scope of work and testing requirements are defined accurately, including turnaround times.
- With Global QC and/or Analytical Development, supports method improvements for tests/assays performed at Contract Testing Labs and coordinates internal Kite support as required
- Up to 25% travel (both domestic and international)
Basic Qualifications:
- Advanced scientific degree (i.e. MD, PharmD, PhD) and 8+ years’ experience of Quality Control Biopharmaceutical experience and OR
- Master’s Degree and 10+ years’ experience of Quality Control Biopharmaceutical experience OR
- Bachelor’s Degree and 12+ years’ experience of Quality Control Biopharmaceutical experience OR
- High School Degree and 16+ years’ experience of Quality Control Biopharmaceutical experience
Preferred Qualifications:
- Advanced science degree.
- Well versed in various analytical techniques such as FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, enzyme assays and other applicable methods to the testing of biopharmaceuticals, preferred.
- Working knowledge of Quality Systems and regulatory requirements (FDA/EMA)
- Minimum 4 years of QC lab management experience in the biotech and/or pharmaceutical industry
- Quality Control, GMPs, bioanalytical method validation
- Strong knowledge of GMP, SOPs and quality control processes
- Identifying, writing evaluating and closing OOS’s and investigations
- Strong knowledge of cell culture techniques
- Equipment/laboratory instrument IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel.
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
- Ability to think critically and demonstrate troubleshooting and problem-solving skills
- Ability to exercise judgement and take appropriate action where precedent may not exist
- Excellent interpersonal, verbal and written communication skills
Does this sound like you? If so, apply today!
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.