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
The salary range for this position is: $169,320.00 - $219,120.00. 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
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