Associate Director, Process Technologies and Development

Associate Director, Process Technologies And Development

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.

Qualified candidates will be part of the process technologies and development group, acting as an interface between formulation scientists and manufacturing operations. The individual will lead the development of processes for both small molecule and large molecule (biologics) parenterals. We are seeking a creative, highly motivated, detail oriented individual to contribute in a cross-functional team setting. The candidate must demonstrate independent critical thinking, have scientific curiosity, be open minded and have an appetite for learning.

Specific Job Responsibilities

• Apply fundamental engineering principles to the design, development, scale-up, and validation of processes for sterile drug product unit operations (e.g., refrigerated / frozen storage and handling of bulk solutions, dissolution of APIs, pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping) for both small molecule and large molecule parenterals
• Support extremely complex technical problems related to sterile processing engineering that advance Gilead portfolio priorities
• Execute studies and author reports related to container closure system compatibility and manufacturing process development
• Play a key role in the establishment of a state-of-the-art sterile process engineering lab
• Evaluate new / novel technologies relevant to parenteral drug product manufacturing
• Represent sterile processing engineering in cross-functional project teams
• Author regulatory filings (IND, NDA, BLA) to support global regulatory submissions
• Serve as a subject matter expert for development and commercial sterile processing operations
• Share expertise and provide guidance / mentorship to support the growth and development of talented junior team members

Knowledge & Skills :

Required Education & Experience

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 the 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.