Senior Scientist I, Pilot Lab Operations - Pre-Pivotal Biologics

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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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.

Job Description

Senior Research Scientist I, Pilot Lab Operations

• Pre-Pivotal Biologics

• Foster City, CA

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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

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. Join Gilead and help create possible, together.

Job Description

The Senior Scientist I, Pilot Lab Operations will be responsible for leading the pilot lab operations including GLP biologics drug substance manufacturing, process transfer, pilot lab facility and equipment readiness, manufacturing operation scheduling, planning, preparation and execution. He/she will provide leadership to ensure timely delivery of GLP drug substances to support toxicology studies as well as developing strategy and technology evaluation to improve pilot plant operation capability, capacity and efficiency. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the successful filings of Gilead's biologics entities.

Key Responsibilities:

• Establish and maintain a state-of-the-art pilot lab for biologics manufacturing process scale up, Research material generation and timely delivery of GLP drug substance for toxicology studies.

• Provide leadership in GLP drug substance manufacturing. Ensure pilot lab facility and equipment readiness. Maintain chemical and consumable inventory. Oversee data generation/data integrity. Hands-on operation planning and execution are expected.

• Collaborate with process development teams to transfer processes into pilot lab, troubleshoot atypical process events. May lead investigations.

• Author, review and/or maintain GLP and non-GMP technical documentation such as batch records, SOPs, guidance documents and reports.

• Train and mentor pilot lab operation team members on authoring GLP documents, pilot scale cell culture and purification operations. Ensure safe pilot lab operations.

• Keep abreast of technology and innovation trends as well as best industry practices to establish highly efficient pilot lab operation. Lead new pilot scale manufacturing technology/innovation evaluation and implementation. Develop strategies and optimize workflows to improve operation efficiency.

• Collaborate with key stakeholder functions including Cell Culture, Purification and Formulation Development to ensure process fit into the pilot lab.

• Adhere to department budget and all training, compliance and safety requirements.

Qualifications:

• Ph.D. in engineering or scientific related field with 2+ years or M.S. with 8+ years or B.S. with 10+ years industrial experience in biologics pilot plant operation.

• Extensive knowledge in single-use manufacturing technology. In-depth experience in cell culture and purification processes. Hands-on experience in pilot scale bioreactor, chromatography and filtration operations. Working knowledge in equipment automation and data management.

• Proven track records in process transfer, raw material and consumables inventory management, pilot lab operation planning, pilot lab facility/equipment maintenance and troubleshooting.

• Demonstrated experience in biologics manufacturing technology evaluation and implementation.

• Experience in developing, authoring and maintaining GLP master batch records, BOMs, SOPs, guidance documents, production reports and pilot lab training program.

• Ability to lead manufacturing operation team in matrix. Experience in mentoring and coaching staff is a plus.

• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.

• Demonstrated ability to collaborate and influence cross-functionally.

• Passion for inclusion: knowing the business value of diverse teams, modelling inclusion, and embedding the value of diversity in the way he/she works.

The salary range for this position is: $177,905.00 - $230,230.00. 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.

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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.