Senior Associate Scientist, Biologics

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 Associate Scientist, Biologics Pilot Lab Operations will lead and execute pilot scale cell culture operations to generate materials to support toxicology studies as well as Process Development activities. They will be responsible for Pilot Lab operation readiness, staff training, innovation and technology evaluation in collaboration with process development groups to improve Pilot Lab operation capacity, efficiency and process productivity. This role is expected to work collaboratively with cross-functional stakeholders and contribute to the successful filings of Gilead’s biologics pipeline.

Key Responsibilities:

• Maintain state-of-the-art upstream Pilot Lab capabilities to support rapid advancement of biologics pipeline through critical development milestones by performing facility fit and material generation runs to enable cell culture process development and scaleup.
• Contribute to material generation planning. Execute pilot scale cell culture operations in Shake flasks, Wave, 100L, and 500L Single Use Bioreactors. Support process scaleup and new technology implementation in the Pilot Lab (e.g. perfusion).
• Provide general lab support with routine maintenance activities, including analytical equipment such as ViCell Blu, NovaFlex, and Cedex Bio.
• Collect and analyze data from Pilot Lab runs in compliance with data integrity policy. Author and review batch records, protocols, project progress updates and production summary reports.
• Transfer process to the Pilot Lab on schedule and with high success rate. Provide technical support for Pilot run atypical event investigations. Escalate as appropriate.
• Author and maintain Pilot Lab work instructions and standard operating procedures.
• Provide hands-on training to Pilot Lab operators.  Mentor junior team members on Pilot Lab operation best practices, batch record completion, operation planning and execution.
• Contribute to biologics manufacturing platform development and new technology/innovation evaluation and implementation to enable fast FIH clinical trial timelines.
• Participate in cross functional initiatives as needed.
• Adhere to department budget and all training, compliance and safety requirements.

Qualifications/Skills/Experience:

• B.S. in Chemical Engineering, Bio-engineering, Biochemical Engineering, Biochemistry or related field with 5+ years (or Master’s with 3 years) of industrial experience in biologics purification development and/or scaleup operations.
• Hands-on experience with pilot-scale cell culture operation planning and execution. Experience in tech transfer process scale-up.

Preferred Experience:

• Working knowledge of single-use manufacturing technologies.
• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.
• Demonstrated ability to collaborate and influence cross-functionally.
• Experience in data analysis (e.g. JMP, Spotfire), creating and maintaining batch records, authoring operation procedures and reports.
• Working knowledge of lab automation, real time data capturing technologies, data management (e.g. Ignition, and DeltaV), data science, knowledge management and data protection 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 works.  

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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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