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Job DescriptionPrincipal Scientist, Analytical Development
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 Sr. Scientist, Analytical Operations, at our Santa Monica, California location. The individual will be an Analytical Sub-team 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 Cross-functional forum
Lead a core Analytical Sub-team 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 sub-teams 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 phase-appropriate validation, etc.
Basic Qualifications:
Bachelor's Degree and Ten Years Experience
OR
Masters' Degree and Eight Years Experience
OR
PhD and Two Years Experience
Preferred Qualifications:
In-depth 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 cross-functional, 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 problem-solving skills, and work with and lead others
Ability to function efficiently and independently in a changing environment
Work independently. Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities
Self-motivated, detail-oriented, excellent interpersonal skills, and willing to accept temporary responsibilities outside of initial job description
People Leader Accountabilities
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
For additional benefits information, visit:
* 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.
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