Associate Director, Clinical QC Analytical & Technical Services

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: September 17, 2020

Job Description:

Associate Director, Clinical QC Analytical & Technical Services Kite is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Kite Pharma Employees and Contractors: Kite is seeking a motivated managerial scientist with experience in QC clinical lot release testing program, analytical method qualification & validation, and method transfer to work on innovative T cell therapy for cancer treatment. The Associate Director, QC Analytical & Technical Services will provide leadership to the 10+ QC team responsible for lot release, technical support, laboratory investigations, CAPA/deviations, post-qualification method improvement and regulatory filing support for Kite’s clinical manufacturing sites producing viral vectors, autologous and allogenic T cell therapy products.

Key responsibilities:

Lead the operational team to maintain first time right metrics of routine lot release testing and the technical team to provide technical expertise and guidance to the quality organization by supporting or managing deviations, investigations, changes, risk assessments and CAPAs.

Develop and support deployment of quality requirements for technologies and/or modalities which require improved analytical methodology with technical acumen

Lead the technical team in the design and execution of technical studies, method qualification and validation

Provide leadership and guidance in incoming method transfers from Analytical Development group and outgoing method transfer to QC commercial sites and/or external business partners

Establish and collect analytical data to serve as metrics, control charts and method trending

In collaboration with Global QC network to evaluate and implement continuous improvement initiatives and method life-cycle management

Promote a culture of quality mind-set and operational excellence.

Qualifications:

Ph.D in Molecular Cell Biology, Immunology, Virology, Biotechnology or equivalent with managing analytical QC laboratory experience

Expertise with cGMP manufacturing knowledge, and FDA/EMA regulatory requirements for clinical biopharmaceuticals, preferably cell therapy products.

Mastery of scientific viral vectors and T-cell therapy principles

Practical experience in clinical GMP laboratory operations with phase appropriate approach

Demonstrated experience with creating and implementing effective cGMP quality systems, inclusive of writing SOPs; product CoA release activities, inclusive of batch record and QC record review; facilitating and closing MRBs/investigations, deviations and associated CAPA

In depth understanding and application of industry standards and cGMP/international regulations and guidelines.

Skills:

Ability to think critically, and demonstrated troubleshooting and problem-solving skills

Excellent interpersonal, verbal and written communication skills

Ability to function efficiently and independently in a changing environment

Self-motivated and willing to accept temporary responsibilities outside of initial job description

Proven ability to lead subordinate staff and work with senior level leaders

The desire and ability to work in a fast-paced environment

Strong collaboration, teamwork, organizational skills with attention to details

Excellent written and verbal communication skills including presentations to cross-functional meetings, senior management and to key external stakeholders

Experience:

Must have at least 5 years of managing pharmaceutical QC labs for product release, method transfer and/or assay development experience

Pharmaceutical products GMP experience is a must

Cell culture or aseptic processing experience is a plus

Previous experience with cell therapy products is a plus

Equipment qualification knowledge in a cGMP environment (IQ, OQ, PQ) is preferred; analytical method qualification, validation and transfer experience is a plus

Experience with LIMS and automation is a plus

Proven track record of leading and managing cross- functional teams

Knowledge of data management tools and statistical controls

#LI-ZN1

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 .

For jobs in the United States: As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact  careers@gilead.com  for assistance.

For more information about equal employment opportunity protections, please view the ‘EEO is the Law’  poster.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Kite Pharma Employees and Contractors: Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.

We are creating Kite together, with the recognition that the best teams are built by the best people. We maintain an attitude of curiosity, and creativity with each challenge as we develop a new market for cancer therapies. We appreciate and respect one another, and most importantly, we don’t take success for granted.

While we’ve come a long way to make what others viewed as impossible, possible, we know one thing is certain. Today is just the beginning.

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Keywords: Gilead Sciences, Inc., Santa Monica , Associate Director, Clinical QC Analytical & Technical Services, Other , Santa Monica, California