Gilead Sciences
Assoc Director, Quality Control - Cell Therapy
Gilead Sciences, Frederick, Maryland, United States, 21701
We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
The Associate Director, Quality Control, will provide oversight for analytical methods of commercial and clinical manufacturing of final cell therapy drug product at kite Pharma's Frederick, Maryland site. They will stage appropriate qualifications, as well as validation and transfer of bioanalytical methods. They will be responsible for in-process, final product testing, and stability testing. Upkeep and maintenance of QC instrumentation and lab in GMP compliance. This role will work with outside testing labs and other Kite sites for method transfers. Accountable for leading and managing the QC Analytical group, its people, projects and timelines.
Job Duties:
Manage in-process, release, and stability testing in support of Commercial and Clinical Manufacturing
Lead QC analytical team to sustain a scalable group to support multiple clinical programs.
Establish user requirements for purchase, qualification of Kite's QC analytical equipment. Work with internal and external resources to maintain equipment in an optimal state.
Responsible for OOS, lab and protocol deviations, Implement corrective action plans when necessary.
Manage the transfer and validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to OTL or other sites. Validation of methods will be phase appropriate.
Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Develop, revise and review SOPs.
Responsible for QC's training. Monitor the GMP systems currently in place to ensure compliance with documented policies
Drive a culture of Operational Excellence in the group
Conduct lab investigations, write deviations, and change controls
Responsible for Data trending, control charts and metrics.
Perform other duties as needed
Basic Qualifications
BS / BA and 8+ years of Quality Control experience or
MS / MA and 6+ years of Quality Control experience or
PhD and 2+ years of Quality Control experience
Preferred Qualifications
Advanced degree in molecular biologist or biochemistry preferred
Candidate who is well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance.
The ideal candidate has strong experience in various analytical techniques: Flow cytometry, ELISAs, PCR, UV and other applicable methods to the testing of cellular therapy products
Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs. Knowledgeable regarding the requirements for analytical testing and phase appropriate qualifications and validations at each stage of clinical development and product approval.
Strong Experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards
Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change control
Ability to effectively negotiate and build collaboration amongst individuals
Demonstrated ability to develop, coach, and mentor key employees
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Previous people leadership experience
The salary range for this position is: $165,495.00 - $214,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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:
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
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.
Kite Pharma 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 apply via the Internal Career Opportunities portal in Workday.
Change The World With Us
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.
Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows.
Job Description
The Associate Director, Quality Control, will provide oversight for analytical methods of commercial and clinical manufacturing of final cell therapy drug product at kite Pharma's Frederick, Maryland site. They will stage appropriate qualifications, as well as validation and transfer of bioanalytical methods. They will be responsible for in-process, final product testing, and stability testing. Upkeep and maintenance of QC instrumentation and lab in GMP compliance. This role will work with outside testing labs and other Kite sites for method transfers. Accountable for leading and managing the QC Analytical group, its people, projects and timelines.
Job Duties:
Manage in-process, release, and stability testing in support of Commercial and Clinical Manufacturing
Lead QC analytical team to sustain a scalable group to support multiple clinical programs.
Establish user requirements for purchase, qualification of Kite's QC analytical equipment. Work with internal and external resources to maintain equipment in an optimal state.
Responsible for OOS, lab and protocol deviations, Implement corrective action plans when necessary.
Manage the transfer and validation of analytical methods from Analytical Development to QC as well as the transfer and validation of methods to OTL or other sites. Validation of methods will be phase appropriate.
Assist in the preparation of dossiers and data packages for interactions between Kite and Regulatory agencies. Interact with agents from Regulatory agencies and participate in Pre-Approval Inspections.
Review of records, generation of CoAs for product release. Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Develop, revise and review SOPs.
Responsible for QC's training. Monitor the GMP systems currently in place to ensure compliance with documented policies
Drive a culture of Operational Excellence in the group
Conduct lab investigations, write deviations, and change controls
Responsible for Data trending, control charts and metrics.
Perform other duties as needed
Basic Qualifications
BS / BA and 8+ years of Quality Control experience or
MS / MA and 6+ years of Quality Control experience or
PhD and 2+ years of Quality Control experience
Preferred Qualifications
Advanced degree in molecular biologist or biochemistry preferred
Candidate who is well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance.
The ideal candidate has strong experience in various analytical techniques: Flow cytometry, ELISAs, PCR, UV and other applicable methods to the testing of cellular therapy products
Familiarity with validation and technology transfer to internal and external analytical labs of both partners and CMOs/CROs. Knowledgeable regarding the requirements for analytical testing and phase appropriate qualifications and validations at each stage of clinical development and product approval.
Strong Experience in applying GMP in QC lab in conformance to U.S., EU, and ROW standards
Experience in conducting lab investigations, writing deviations, implementing CAPA and initiating change control
Ability to effectively negotiate and build collaboration amongst individuals
Demonstrated ability to develop, coach, and mentor key employees
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Previous people leadership experience
The salary range for this position is: $165,495.00 - $214,170.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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:
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)
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.
Kite Pharma 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 apply via the Internal Career Opportunities portal in Workday.
Change The World With Us
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.