Director of Global Manufacturing Sciences and Technology Validation
Santa Monica, CA, USA | Gilead Sciences
Industry:Pharmaceutical / Biotech
Operations / Production
Job Description:77 people have viewed this job
At Kite, we are at the forefront of immunotherapy and engineered T cell therapy. We are helping change the paradigm of cancer treatment, and we are revolutionizing individually tailored treatments. That means a fast moving and constantly changing environment, where we make discoveries every day – discoveries that include our own capabilities and our individual potential.
We are seeking a highly motivated leader to join as a Director of Global Manufacturing Sciences and Technology (MSAT) Validation. This individual will provide strategic leadership for novel technology qualification, product comparability, process validation and GMP manufacturing for Kite’s engineered autologous T cell therapy products and viral vector programs. Additionally, the Director will define technical requirements and lead comparability and process validation project plans and protocols, sampling plans, production procedures, and process development reports, and provide technical assessments, rationales and approval for engineering and process changes as well as documentation pertaining to process development, equipment qualification, and validation to meet regulatory requirements. Lastly, the Incumbent will work with the Process Design, Manufacturing and Quality teams to implement cell therapy processes to multiple sites, establish novel technology and equipment qualification strategies and lead all aspects of process validation, as well as draft documentation for regulatory filings to advance Kite’s product portfolio.
Lead, develop and implement scientifically sound and fit for purpose global validation policies and procedures based on current regulations, industry standards and industry practices for cell therapy.
Create and promote process validation standards, process qualification strategy and framework for cell therapy processes, continuous process verification (CPV) strategy and implementation in a consistent manner across products and sites. This includes providing leadership and direction for Site MSAT and manufacturing Technical SMEs to define the validation requirements for execution of aseptic or closed system process.
Develop and maintain qualification responsibilities include technical support for equipment qualification standards, framework for harmonized risk-based qualification strategies for similar equipment and unit operations across plants and alignment of PQ activity with process and operational requirements.
Based on product and process lifecycle requirements, define and establish sound scientific approaches for risk evaluation of global process change impact on process validation and comparability.
Interface internally with process design, analytical development, technical development, Global/Site MSAT and process technical leads and cross-functionally with Quality, Manufacturing and Engineering to implement new processes and technology as part of technology transfers.
Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
Work with vendors and suppliers to define requirements and understand functional specifications.
Support investigation, identify root cause for critical deviations during process validation and resolve CAPA for manufacturing.
Write, Review/Approve user documentation such as validation master plans, protocols & reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process and cell therapy manufacturing process validation testing in alignment with Kite Global SOPs.
Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and solving equipment process issues.
Be capable of developing, growing and leading technical talent in cell therapy equipment qualification and process validation
10+ years of equipment and process validation, technology transfer or pharmaceutical manufacturing experience and a MS or MBA degree or; 12+ years of the aforementioned experience and bachelor’s degree in science or related field.
15+ years of equipment and process validation, technology transfer or pharmaceutical manufacturing experience
Cell culture, cell therapy or aseptic processing experience
Equipment qualification experience in a cGMP environment (IQ, OQ, PQ) with process validation experience
Understands and employs principles and concepts of Lean Six Sigma to improve process capability
Experience in statistical analysis using JMP or Minitab
Consistent record of leading and running multi-functional teams
Knowledge of data management tools and statistical process
Ability to think critically, and demonstrated problem-solving skills
Excellent interpersonal, verbal and written communication skills as well as digital literacy
Ability to function efficiently and independently in a changing environment
Proactive and willing to accept temporary responsibilities outside of initial job description
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