Scientist, Process Development

Scientist / Sr. Engineer 1, Global Biologics Dp Msat

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.

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.

As a member of Global Biologics Manufacturing Sciences and Technology (MSAT), the Scientist / Sr. Engineer 1, Global Biologics DP MSAT role is responsible for providing technical expertise to drive technology transfer and production activities for late-stage clinical & commercial biologic drug product manufacturing processes. Project scope may include introduction of new products to existing internal / external filling lines, transfer to new contract manufacturing partners, and manufacturing support of existing products. The incumbent will engage and collaborate with internal and external partners to ensure drug product process transfers are executed to ensure technical and regulatory success. They will support the design and execution of validation studies during process performance qualification (PPQ) and contribute to authoring of process transfer documents, risk / gap assessments, validation protocols / reports, and regulatory filings.

The individual may also serve as a subject matter expert in support of GMP change management, manufacturing investigations, and ongoing process monitoring. They will also serve as a functional representative working with internal and external manufacturing sites to establish commercial processes for Gilead products, implement continued process verification, and provide ongoing support to ensure uninterrupted market supply.

Job Responsibilities

• Represent Global Biologics MSAT group on project teams as a subject matter expert for sterile fill / finish activities including process transfer and validation.
• Contribute to project workstreams such as facility fit, risk assessments, control strategy development, validation strategy, change management. Author reports associated with these activities.
• Follow GMP change management procedures to ensure timely and successful implementation of new processes and subsequent changes. Partner with process development, quality, and regulatory affairs during investigations to address OOS, OOT, and complex deviations.
• Collaborate with process development group to support process characterization activities and establishment of design space to enable commercial tech transfer and validation. Participate in internal development teams as MSAT representative.
• Review technical documentation including protocols, master batch records, and reports for engineering runs, GMP and PPQ campaigns.
• Contribute to process validation sections of regulatory filings in support of commercial launch / expansion.
• Participate in cross functional business and scientific initiatives as MSAT representative, and effectively collaborate and influence cross-functional partners to support team objectives.
• Up to 20% travel in support of the above activities

Basic Qualifications

Preferred Qualifications