At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
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 Gilead and help create possible, together.
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 a highly motivated individual to join us as an Associate Director, to lead Quality Control Analytical Tech Services group, reporting to the Senior Director, Quality Control in Frederick, MD. In this role, you will lead a group and work closely with the Senior Director and other Associate Directors on supporting commercial operations in CAR-T technology.
You will work on complex projects involving qPCR/ddPCR, Flow cytometry and cell-based bioassays and lead efforts in automation development for analytical assays. You will have cross-functional interaction with personnel from other groups such as Quality Assurance, Analytical Development, Manufacturing, Material Management (MM) and Corporate teams.
Position Responsibilities (include but not limited to):
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Provide technical support, process trending and procedural updates
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Lead method validation and method transfers support continuous improvement, to support method/product/invalid trending, and to investigate laboratory/assay related findings.
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Lead and support method development, validations, and transfers
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Support laboratory investigations, deviations, CAPAs, change control as needed
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Assist in investigation, identify root cause for critical deviations and determine CAPA for QC as needed
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Establish data analytics to serve as metrics for monitoring trends in methods, products, and invalids
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Support incoming tech transfers from AD/PD as needed
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Author technical reports and protocols in support of cGMP activities
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Supervise, train, and mentor junior staff
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Create and/or revise procedures, SOPs, and test methods as needed
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Support equipment and software lifecyle process
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LIMS development and integration
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Provide technical expertise for AD/PD, QA, Regulatory, Manufacturing, and Supply Chain as needed
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Support and participate inspection readiness plans and participate during compliance audits (internal and external) and regulatory inspections.
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Follow technology changes, recommends new technologies, advises on technology purchases and implementation if appropriate.
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Additional duties as assigned.
Basic Qualifications:
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Advanced scientific degree (i.e. MD, PharmD, PhD) and 2+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
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Master’s Degree and 8+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
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Bachelor’s Degree and 10+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment OR
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High School Degree and 14+ years’ experience in biologics/cell-gene therapy in QC Analytical, Analytical Development environment
Preferred Qualifications:
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Experience supervising/managing analytical labs within the biotechnology or pharmaceutical industry
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Well versed and experienced in bioanalytical methods working under GMP conditions.
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Deep experience in applying GMP in QC lab in conformance to US, EU and ROW standards.
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Experience in conducting investigations, writing deviations, implementing CAPA and initiating change controls.
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Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211), Quality Control, GMPs, GLP
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Ability to effectively negotiate and develop collaboration within teams and amongst individuals.
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Demonstrated ability to create and maintain highly functioning teams.
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Excellent interpersonal, verbal and written communications skills which are essential in this collaborative work environment
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Comfortable in a fast-pace small company environment with minimal direction and able to adjust workload based on changing priorities.
Does this sound like you? If so, apply today!
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The salary range for this position is: $161,755.00 - $209,330.00. Gilead 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.
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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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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.
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