Address
Form of workFor Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Kite we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description
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 an experienced Product Quality Lead to manage the transition of our clinical cell therapy products to the commercial market. The ideal candidate will have a strong understanding of the clinical development process and experience in commercial product quality management. You will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet clinical, 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. You will help to define the operational Quality and Compliance strategy and will be active in the execution of the strategies supporting the clinical and commercial Operations Team.
As a product expert in Quality, the Product Quality Lead role has responsibility for working directly with Operations Leaders, Quality Control (QC), Regulatory Affairs, Process Development (PD), Quality Assurance (QA), Qualified Persons, internal and external Manufacturing (CMO) 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 (implementation of new methods, transfers, validation, performance and improvements), establishment of and revisions to 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.
Duties & Responsibilities:
Basic Qualifications:
Preferred Qualifications / Skills:
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.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kongemployees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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:
Please log onto your Internal Career Site to apply for this job.
Please log onto your Internal Career Site to apply for this job.
At Kite we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description
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 an experienced Product Quality Lead to manage the transition of our clinical cell therapy products to the commercial market. The ideal candidate will have a strong understanding of the clinical development process and experience in commercial product quality management. You will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet clinical, 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. You will help to define the operational Quality and Compliance strategy and will be active in the execution of the strategies supporting the clinical and commercial Operations Team.
As a product expert in Quality, the Product Quality Lead role has responsibility for working directly with Operations Leaders, Quality Control (QC), Regulatory Affairs, Process Development (PD), Quality Assurance (QA), Qualified Persons, internal and external Manufacturing (CMO) 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 (implementation of new methods, transfers, validation, performance and improvements), establishment of and revisions to 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.
Duties & Responsibilities:
- Lead the development and implementation of product quality plans and procedures for commercialization
- 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 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 Product Quality Team. Act as delegate to 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
- Support product quality data monitoring programs
- Lead the development and implementation of product quality plans and procedures for commercialization
- Work with CMOs to define compliance requirements with cGMPs and all relevant regulations
- Support filing and RTQ for commercial approval
Basic Qualifications:
- PhD OR
- Master's Degree and 6+ years' experience in biotech / biopharma, technical operations OR
- Bachelor's Degree and 8+ years' experience in biotech / biopharma, technical operations OR
- High School Degree and 12+ years' experience in biotech / biopharma, technical operations
Preferred Qualifications / Skills:
- 3+ years working in a regulated environment (either direct GMP or technical support)
- Excellent interpersonal, verbal and written communication skills, including facilitation and presentation skills, are essential in this collaborative work environment.
- Communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences.
- Ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
- Must be able to work on multiple projects simultaneously and demonstrate ability to organize, prioritize and manage time
- Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities.
- Experience with authoring or review of biological license applications/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation, highly desired.
- Experience supporting non-conformance investigations, authoring, reviewing and defending critical product impacting non-conformances
- 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.
- Experience working with CMOs and a strong understanding of cGMPs and regulatory requirements
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.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kongemployees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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:
Please log onto your Internal Career Site to apply for this job.
