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Commercial Product Quality Leader

Company: Gilead Sciences, Inc.
Location: Santa Monica
Posted on: September 13, 2020

Job Description:

United States - California - Santa Monica

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: 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!

We are seeking a Commercial Product Quality Leader for Kite’s commercial products. You will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet late-stage and commercial product goals. As a product expert in Quality, this role has the responsibility for technical expertise and project support for the Quality and Compliance aspects of the product throughout its life cycle (i.e., life cycle management). You will help to define the operational Quality and Compliance strategy with the Commercial Product Quality Director and will be active in the execution of the strategies supporting the commercial Operations Team.

As a product expert in Quality, the Commercial Product Quality Leader role has responsibility for working directly with Operations Leaders, Quality Control (QC), Regulatory Affairs, Process Development (PD), Quality Assurance (QA), Qualified Persons, and Manufacturing on the resolution of issues and implementation of strategies associated with cell therapy products. This includes topics related to technology transfers, manufacturing process improvements, in-process control and critical quality attribute trends, analytical methods (transfers, validation, performance and improvements), product and starting material specifications, reference standards, importation testing, investigations, change controls, regulatory submissions, annual product reviews, risk assessments and regulatory inspections related to product(s). Your work will drive initiatives intended to ensure the overall product health.

Other responsibilities include (but are not limited to):

Provide quality leadership on cross-functional teams in a matrix environment, driving alignment and decision making, performing a scientifically sound and risk-based evaluation of process and product quality data, and developing patient-oriented strategies.

Execute/drive product strategies under the direction of the Director, Product Quality through strong quality and scientific leadership related to technology transfers, global regulatory filing strategies, analytical method improvements, stability, product specifications and program improvements.

Support operationalizing theoretical concepts (e.g. product strategies) into actionable plans and execute those plans with successful outcomes.

Negotiate plans with regulatory authorities and internal multi-functional teams to obtain the optimal product quality position for life cycle management

Actively participate in the global Commercial Product Quality Team. Act as delegate to Commercial Product Quality Director for the Product Quality Team, as needed.

Author sections of regulatory submissions, as directed

Help develop the Stability strategy of the Product

Monitor Product Quality Data

Lead authorship of the Annual Product Review, as assigned, for commercial marketed products

Qualifications

PhD/MS in biochemistry, biology, regulatory sciences, engineering or a related protein/biotechnology sciences field and minimum 3+ years of directly related experience in late-stage/commercial biologic products OR Bachelor’s degree in biochemistry, biology, engineering or a related protein/biotechnology sciences field and 8+ years of directly related experience in late-stage/commercial biologics

3+ years working in a regulated environment (either direct GMP or technical support)

Experience with authoring or review of biological license applications/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation (i.e. review cycle questions), highly desired.

Experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances

Communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.

Excellent written and verbal communication skills, including facilitation and presentation skills.

Ability to influence others through persuasive interactions and garner support for novel solutions where applicable.

Ability to work and navigate within an evolving scientific and regulatory environment.

Familiarity with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions, preferred.

Experience in direct interaction with regulatory agencies/Boards of Health during inspections

Understanding of biologic product development and manufacturing principles.

Knowledge of cGMP and filing regulations, guidelines, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals is preferred.

Previous experience working on a cross-functional team in a matrix environment is a plus.

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: Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community

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Keywords: Gilead Sciences, Inc., Santa Monica , Commercial Product Quality Leader, Other , Santa Monica, California

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