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Foster City, California, United States
Onsite
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
The Senior Scientist, Cell Culture Process Development (Pivotal & Commercial), will be responsible for leading aspects of cell culture development including commercial process development and process characterization for multiple biologics programs during pivotal phases (phases II/III and post-launch). In addition, this role is also expected to lead projects for cell culture process technology development, platform process evolution, and to support cell culture-related regulatory documentation.
Key Responsibilities:
Optimize and characterize cell culture processes to supply pivotal trials and enable commercialization for monoclonal antibodies, multi-specifics, and novel modalities.
Lead and/or support entire lifecycle of pivotal activities including process risk assessment, process characterization, preparation of all supporting documentation/reports toward BLA submission, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA.
Lead and/or support technology transfer and investigation activities in partnership with the global manufacturing sciences and technologies (MSAT) group.
Design experiments and perform hands-on cell culture operations in shake flasks, ambr15, ambr250, bench-scale bioreactors, and novel cell culture platforms.
May provide support to pilot plant operation for up to 500 L single-use bioreactor.
Perform statistical analyses and appropriate modeling to assess process parameter criticality, identify acceptable ranges, and contribute to integrated control strategy.
Author and review GMP and non-GMP technical documents (reports, regulatory submissions/responses, batch records, SOPs etc.), present in group/cross-functional meetings.
Participate and work cross-functionally within and outside of biologics technical development to achieve common goals.
Explore, develop, and implement novel cell culture technologies to meet business needs.
Manage direct and indirect reports and mentor junior group members while working in a flexible and agile environment.
Some travel may be required to support technology transfers and provide oversight at external manufacturing facilities.
Adhere to department budget and all training, compliance and safety requirements.
Remain current on trends and new technology advancements across the Biopharmaceutical industry.
Hire, mentor and develop team members within the organization to help build and grow a world-class biologics cell culture process development organization.
Basic Qualifications:
Bachelor's Degree and Eight Years' Experience
OR
Masters' Degree and Six Years' Experience
OR
PhD / PharmD
Preferred Qualifications:
Ph.D. with 3 + years of industry experience.
Experience leading pivotal stage cell culture process development/characterization and implementation in GMP facilities.
Experience in building high-performing teams through strategic coaching and feedback.
Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor, and pilot scale cultures.
Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
Demonstrated ability to collaborate and influence cross-functionally.
Experience in cell culture media development, and/or employing modeling techniques for upstream process development and optimization is preferred.
Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
Working knowledge of lab automation, data management, data science, knowledge management and data protection.
Experience with viral vaccines is a plus.
Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she/they work.
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 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:
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.
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 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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YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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.