Kite Pharma
Supervisor, Quality Control Lab Support
Kite Pharma, Frederick, Maryland, United States, 21701
Job Opportunity At Kite Pharma
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
Kite is seeking a highly-motivated individual to join us as a Supervisor, reporting to the Manager, Quality Control in Frederick, MD. In this role, you will be responsible for tasks associated with managing a group responsible for Sample Management, Shipping, and Lab Services QC functions, and have cross-functional interaction with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing and Corporate teams. The position is primarily responsible for providing guidance to the QC Lab Support function. This group will operate 7 days a week, with an extended, overlapping shift structure. You will be responsible for the day-to-day oversight of the QC Lab Support team during a 40-hour work week. Shift - Mon-Fri 3pm to 12am Additional Responsibilities (include but are not limited to): Maintain and oversee processes to support sample receipt, chain of custody, storage, and processing for release and stability testing. Oversee shipment of samples to internal and external testing labs. Supervise the QC Lab Support team and ensure efficient operation of sample logistics in support of QC testing, manufacturing, and stability programs. Review and approve sample-related documentation including chain of custody, shipment records, logbooks, and electronic data entries (e.g., LIMS). Complete routine review of records related to sample management, including samples, reagents, materials, and retains. Hire, mentor, and develop QC Lab Support staff to support a high-performing, scalable team structure. Provide coaching, performance feedback, and career development. Manage the QC Lab Support training program. Generate Certificates of Analysis (CoAs) for product release. Lead or support investigations, deviations, and CAPAs related to sample handling discrepancies, shipping errors, or storage excursions. Author, implement, and review changes to controlled documents. Participate in audits and inspections as the subject matter expert (SME) for QC Lab Support operations. Represent QC Sample Management in cross-functional meetings and provide regular updates during daily and weekly team huddles. Monitor the GMP systems currently in place to ensure compliance with documented policies. Support and lead initiatives related to Lean Lab and Operational Excellence to enhance efficiency. Review and provide input on proposed changes to sample management procedures, systems, and quality documentation. Perform other duties as assigned. Basic Qualifications: MA/MS Degree with 3+ years of Quality Control and/or cGMP operations and/or quality experience OR BA/BS Degree with 5+ years of Quality Control and/or cGMP operations and/or quality experience Preferred Qualifications: Demonstrated ability to develop, motivate, and mentor key employees Demonstrated ability to lead a functional area with multiple shifts Well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance Meaningful 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 develop collaboration amongst individuals 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 on changing priorities. Does this sound like you? If so, apply today! The salary range for this position is: $107,185.00 - $138,710.00. 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. 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. For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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. 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.
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
Kite is seeking a highly-motivated individual to join us as a Supervisor, reporting to the Manager, Quality Control in Frederick, MD. In this role, you will be responsible for tasks associated with managing a group responsible for Sample Management, Shipping, and Lab Services QC functions, and have cross-functional interaction with personnel from other QC groups, Quality Assurance, Analytical Development, Manufacturing and Corporate teams. The position is primarily responsible for providing guidance to the QC Lab Support function. This group will operate 7 days a week, with an extended, overlapping shift structure. You will be responsible for the day-to-day oversight of the QC Lab Support team during a 40-hour work week. Shift - Mon-Fri 3pm to 12am Additional Responsibilities (include but are not limited to): Maintain and oversee processes to support sample receipt, chain of custody, storage, and processing for release and stability testing. Oversee shipment of samples to internal and external testing labs. Supervise the QC Lab Support team and ensure efficient operation of sample logistics in support of QC testing, manufacturing, and stability programs. Review and approve sample-related documentation including chain of custody, shipment records, logbooks, and electronic data entries (e.g., LIMS). Complete routine review of records related to sample management, including samples, reagents, materials, and retains. Hire, mentor, and develop QC Lab Support staff to support a high-performing, scalable team structure. Provide coaching, performance feedback, and career development. Manage the QC Lab Support training program. Generate Certificates of Analysis (CoAs) for product release. Lead or support investigations, deviations, and CAPAs related to sample handling discrepancies, shipping errors, or storage excursions. Author, implement, and review changes to controlled documents. Participate in audits and inspections as the subject matter expert (SME) for QC Lab Support operations. Represent QC Sample Management in cross-functional meetings and provide regular updates during daily and weekly team huddles. Monitor the GMP systems currently in place to ensure compliance with documented policies. Support and lead initiatives related to Lean Lab and Operational Excellence to enhance efficiency. Review and provide input on proposed changes to sample management procedures, systems, and quality documentation. Perform other duties as assigned. Basic Qualifications: MA/MS Degree with 3+ years of Quality Control and/or cGMP operations and/or quality experience OR BA/BS Degree with 5+ years of Quality Control and/or cGMP operations and/or quality experience Preferred Qualifications: Demonstrated ability to develop, motivate, and mentor key employees Demonstrated ability to lead a functional area with multiple shifts Well versed and experienced in bioanalytical methods and experience in managing a Quality Control laboratory under GMP compliance Meaningful 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 develop collaboration amongst individuals 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 on changing priorities. Does this sound like you? If so, apply today! The salary range for this position is: $107,185.00 - $138,710.00. 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. 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. For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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. 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.