Principal Scientist, Analytical Ops
Principal Scientist, Analytical Ops
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$ 177905 - 230230
1 Vacancy
Job Description
Were 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. Weve made incredible scientific breakthroughs and our pioneering personalized CAR Tcell therapies have changed the paradigm. But were 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
We are seeking a highly motivated individual with a background in CMC analytical control strategy and method lifecycle management experience of Advanced therapy medicinal products to join us as a Principle Scientist Analytical Operations at our Santa Monica California location. The individual will be an Analytical Subteam Lead (ASTL) in Analytical Development who will work within cross functional groups with process development quality regulatory to lead the implementation of the analytical control strategy through the lifecycle of a program.
Responsibilities include (but are not limited to):
Lead the overall implementation of the analytical control strategy
Enable Analytical readiness for success of IND/BLA filings
Serves as an analytical team Representative in Crossfunctional forum
Lead a core Analytical Subteam within analytical to oversee the Analytical Control Strategy of program(s)
Create analytical roadmaps and timelines with trackable key milestones that clearly reflect the CMC strategy
Define and track project decisions risks action items sampling plan etc.
Lead the efforts of method deployment to Quality Control. Strategic partner with Quality Control representing Analytical function in Product Quality Team
Strategic partner with Process Development representing Analytical in Product Development Team
Provide regulatory filing support as needed as an Analytical Representative
Collect feedback from Analytical subteams to continue improving business processes
Besides being a strategic lead the ASTL is accountable for many operational deliverables like own program specific meetings Analytical program risk register oversee sampling plan from method development and phaseappropriate validation etc.
Basic Qualifications:
PhD and 5 years of related industry
OR
Masters Degree and 8 years of related industry experience
OR
Bachelors Degree and 10 years of related industry experience
Preferred Qualifications:
Indepth experience of CMCs/cGMPs for Advanced therapy medicinal products (Cell Therapy and viral vectors for gene therapy)
Understand ICH guidelines and other regulatory guidelines and requirements
Basic knowledge in analytical techniques such as Flow cytometry ddPCR Potency and compendial methods techniques
Project management experience and proficient in project management tools
Excellent interpersonal verbal and written communication skills
Ability to lead a crossfunctional diverse experienced strategic and technical staff
Ability to influence and lead without authority influencing others and achieving desired outcomes through persuasion collaboration and building trust
Ability to think critically and demonstrate troubleshooting and problemsolving skills and work with and lead others
Ability to function efficiently and independently in a changing environment
Work independently. Comfortable in a fastpaced environment with minimal direction and able to adjust workload based on changing priorities
Selfmotivated detailoriented excellent interpersonal skills and willing to accept temporary responsibilities outside of initial job description
For additional benefits information visit:
Gilead Sciences Inc. 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 disabilitygenetic information or characteristic gender identity and expression veteran status or other nonjob 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 for assistance. NOTICE: EMPLOYEE POLYGRAPH PROTECTION 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. Please apply via the Internal Career Opportunities portal in Workday.
Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid longterm 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 systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTFor Current Kite Pharma Employees and Contractors:
Required Experience:
Staff IC
Employment Type
Full-Time
