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Associate Director, Analytical Ops

United States - California - Santa MonicaQualityRegular

Job Description

Kite Pharma, a Gilead company, is seeking a highly motivated Associate Director of Quality Control (QC) to support its existing and expanding sites globally. This role will provide oversight and support execution, optimization, transfer, qualification, and validation of analytical methods for lot release of raw material, within a Good Manufacturing Practices (GMP) environment. The successful candidate will have experience executing analytical test methods, and GMP method qualification and validation. This role requires interaction with Process Development, Supply Chain, Quality Assurance and Regulatory Affairs.

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. Join us in our mission!

Kite is seeking a highly motivated individual and experienced leader to join Kite as an Associate Director, Global Quality Control, to provide Quality Control oversight of Global Raw Materials and Reagents Center of Excellence.

Responsibilities include (but are not limited to):

  • Develop a team of subject matter experts and technical leads for analytical methods in commercial and clinical phase programs that include method related investigations, optimization and development. Analytical techniques include HPLC, LC-MS, FACS, ELISAs, PCR, FT-IR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents.
  • Establish robust analytical development strategies, inclusive of method qualification and validation, to ensure product quality and meet regulatory requirements.
  • Providing technical and scientific leadership relating to support of analytical operations on troubleshooting in QC and long-term strategic improvements
  • Generate release specifications for raw materials and products.
  • Direct technical root-cause investigations for OOS, deviations and CAPAs relating to analytical methods.
  • Perform risk assessments, gap assessments for analytical methods and aim to enhance compliance and robustness.
  • Monitor health of methods across the product portfolio to identify common trends or major risks and recommends appropriate technology solutions for implementation
  • Lead communication between Analytical development, Process Design and Quality control (internal and external partners) by communicating requirements and directly participate in the development and implementation of new and optimized methods.
  • Support method and analytical investigations with contract testing labs and Kite facilities as appropriate.
  • Ensure standard operating procedures, analytical test methods, analytical sampling plans, batch records, and monitoring, trending and improvement process for all Kite analytical methods meet the highest industry standard.
  • Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the QC function remain in compliance with applicable company requirements and global regulations.
  • Develop, revise, review and approve SOPs, methods, qualification/validation protocols and reports.
  • Monitor the GMP systems currently in place to ensure compliance with documented policies.
  • Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
  • Supports CMC teams in preparing and/or reviewing dossier and responses to follow-up questions to post-approval change submissions.
  • Work with a cross-functional development team to advance development of autologous T cell therapy products.
  • Participate in PAI, defend regulatory audits and draft response.
  • Liaise with other departments to ensure business continuity including, quality, manufacturing, supply chain, Ex warehousing, and PD/MSAT

Basic Qualifications:

  • Advanced scientific degree (i.e. MD, PharmD, PhD) and 2+ years’ experience in analytical development, QC, technology transfers and method lifecycle management OR
  • Master’s Degree and 8+ years’ experience in analytical development, QC, technology transfers and method lifecycle management OR
  • Bachelor’s Degree and 10+ years’ experience in analytical development, QC, technology transfers and method lifecycle management OR
  • High School Degree and 14+ years’ experience in analytical development, QC, technology transfers and method lifecycle management

Preferred Qualifications:

  • Strong working knowledge, expertise and troubleshooting in analytical method development, validation and cGMP requirements and testing in clinical and commercial QC. Experience with gene and cell therapies preferable. Analytical techniques include HPLC, LC-MS, FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, Gel/ Western Blot, enzyme assays, microbiological assays, and other applicable methods to the testing of Raw Materials and Reagents.
  • Experience with Root Cause Analysis (RCA) methodologies and tools
  • Strong interdepartmental communication skills, with history of leading cross-site meetings.
  • Experience working within multi-jurisdictional (USP/EP/JP/ChP) pharmacopeia guidelines.
  • Owned Change Controls and CAPAs.
  • Identifying, writing evaluating and closing OOS’s and investigations
  • Equipment and utility IQ/OQ/PQ/PV
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
  • Ability to write up technical assessments and that use modern risk management methodology.
  • Proven leadership in method optimization and remediation, CMC tech- transfer, analytical control strategies and method validation
  • Shown ability to work with both direct reports and senior management
  • Ability to lead a diverse, experienced technical staff team with attention to detail, to think critically and demonstrate troubleshooting and problem-solving skills, and work with and lead others
  • Strong knowledge of technical writing for BLA, IND
  • Proficient in MS Word, Excel, Power Point and other applications
  • Ability to function efficiently and independently in a changing environment
  • Self-motivated, detail-oriented, excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills, and excellent interpersonal, organizational, and written and oral communication skills.