Associate Scientist, Analytical Tech Transfer Lead

Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Associate Scientist, Analytical Development (27)

We are seeking a highly motivated individual with a background in analytical method transfer and lifecycle management experience to join us as Associate Scientist, Analytical Operations, at our Santa Monica, California location. The individual will work within cross functional groups in analytical development, process development and quality control to facilitate interdepartmental and external analytical method transfers and life cycle management. With appropriate guidance, this individual will also lead building an extensive method monitoring program and implementation of new technologies.

Responsibilities include (but are not limited to):

• Manage and lead analytical technology transfer for new programs and external partners

• Facilitate clinical and commercial method transfers from external partners/research to AD and from AD to customer facilities like QC by authoring transfer documentation and training plans, and providing review of validation protocols and reports to meet filing standards

• Maintain project timelines and dashboards for visibility to product team

• Develop cross-functional method monitoring methodologies and perform statistical analysis as part of life cycle direction to promote critical thinker changes to methods

• Ensure standard operating procedures, analytical test methods, analytical sampling plans, and monitoring, trending and improvement processes for analytical methods to meet the highest industry standard

• Coordinate activities to support investigational troubleshooting of methods in Clinical and Commercial Quality Control during and post technology transfer

• Engage at cross-functional AD/QC meetings including Method Monitoring Working Teams and Software Alignment teams to ensure consistent analytical testing across the Kite network

• Lead gap and risk assessments to enable LCM of analytical methods to meet milestones for continuous improvement of commercial programs

Basic Qualifications:

• Master’s Degree and 3+ years of related industry/academic experience OR

• Bachelor’s Degree and 5+ years of related industry/academic experience OR

• High School Degree and 9+ years of related industry experience

Preferred Qualifications:

• In-depth experience with CMC technology transfer and cGMP requirements and testing in Clinical and Commercial Quality Control; experience with cell therapies is a plus

• Project management experience and proficient in project management resources such as Smartsheets, Spotfire, Clarity.

• Knowledge of biostatistics and method monitoring/trending analysis on JMP/Prism or other analysis software

• Ability to lead a cross-functional, diverse, experienced technical staff

• Ability to think critically and demonstrate troubleshooting and problem-solving skills, and work with and lead others

• Basic knowledge in analytical techniques such as Flow cytometry, qPCR, ddPCR, ELISA and compendial methods techniques

• Proficient in MS Word, Excel, Power Point and other applications

• Ability to function efficiently and independently in a changing environment

• Comfortable in a exciting small company environment with minimal direction and able to adjust workload based upon changing priorities

• Self-motivated, detail-oriented, excellent interpersonal and writing skills, and willing to accept temporary responsibilities outside of initial job description

• Excellent interpersonal, verbal and written communication skills

The salary range for this position is: $101,830.00 - $131,780.00. 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.

For jobs in the United States:

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 careers@gilead.com for assistance.

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