Scientist - Cell Culture Process Development (Pivotal & Commercial)

For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.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 DescriptionThe 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 filing, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA.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 filings/responses, batch records, SOPs etc.), present in group/cross-functional meetings.Participate and work cross-functionally 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.Basic Qualifications:Ph.D. in Chemical Engineering, Biochemistry, or related fields OR M.S. with 4+ years of relevant experience OR B.S. with 6+ years of relevant experience.At a future date, this position will relocate to the corporate headquarter in Foster City, CA.Preferred Qualifications:Strong understanding and extensive hands‐on experience in cell culture process development. In-depth knowledge of mammalian cell culture processes including molecular biology & cell engineering concepts, media design, bioreactor scale-up, mass transfer, bioreactor control, single use and stainless bioreactor systems. In-depth knowledge of industry best practices & trends.Solid understanding and experience in statistics and data analyses.Experience in mammalian cell culture process development and pivotal development, process characterization and commercial support of cell culture operations from seed train to production.Experience in process transfer to manufacturing facilities and technical leadership in process troubleshooting.Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and experience authoring CMC sections in commercial regulatory filings (BLA, MAA) and post approval changes is a plus.Working knowledge in lab automation, data science, knowledge management, single-use manufacturing technology and cGMP guideline is a plus.Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.People Leader Accountabilities:Create Inclusion - knowing the business value of diverse teams, modelling 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, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.Gilead Core Values:Integrity (Doing What’s Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)The salary range for this position is: $143,225.00 - $185,350.00. 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: * 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 ApplicantAccommodations@gilead.com for assistance.For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACTYOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACTPAY TRANSPARENCY NONDISCRIMINATION PROVISIONOur 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.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.SummaryLocation: United States - California - Foster CityType: Full time