Senior Biologics Engineer II

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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.
 

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
 

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

The Senior Biologics Engineer II (Drug Substance) role is focused on commercial manufacture technical oversight. We are seeking motivated, team-oriented individuals with expertise in biopharmaceutical drug substance processing.  The individual will serve as a key subject matter expert (downstream) for commercial manufacture oversight, process monitoring, capital improvements, risk assessments, and process validation where applicable.  They will also serve as a key functional representative working with Contract Manufacturing Organizations to establish commercial manufacturing processes for Gilead products, implementing continuous process verification, and providing technical leadership during quality investigations and pre-approval inspections. 

Job Responsibilities

• Represent Manufacturing, Science and Technology (MSAT) on project core teams and sub-teams as a Subject Matter Expert (SME) to coordinate multi-functional activities to support commercial manufacture of drug substance.  Lead or contribute to project workstreams such as risk assessments, control strategy management, continuous improvement, and change management throughout the product lifecycle.
• Collaborate with Process Development group to support continuous improvement initiatives.  Participate in internal development teams as MSAT representative.
• Review and approve technical documentation including protocols, master batch records, deviation records, and reports for commercial campaigns.
• Author manufacture sections of regulatory filings in support of commercial product lifecycle management.  Ensure regulatory inspection readiness and product compliance with regional regulatory requirements.
• Implement business and quality change management procedures to ensure timely and successfu