Manager, Biologics Pilot Lab Operations - Pre-Pivotal 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 Manager, Biologics Pilot Lab Operations, will be responsible for coordinating biologics pilot lab operations including GLP drug substance manufacturing, pilot lab facility and equipment readiness, manufacturing operation scheduling, planning, preparation and execution as well as supporting process scaleup. He/she will support process transfer and timely delivery of protein therapeutics to support toxicology studies and Research activities. This role will develop, coordinate and execute plans to improve pilot lab operation capability, capacity and efficiency.

Key Responsibilities:

Maintain a state-of-the-art biologics pilot lab for manufacturing process scale up and timely delivery of therapeutic proteins to support process development, toxicology studies and Research activities.

Coordinate, plan, execute and document therapeutic protein material generation runs. May lead projects in the biologics pilot lab.

Ensure pilot lab facility and equipment readiness in collaboration with site supporting functions. Procure and maintain chemical and consumable inventories.

Support process transfer into pilot lab and atypical process event trouble shooting in collaboration with key stakeholder functions including Cell Line Development, Cell Culture, Purification and Formulation Development.

Author and maintain GLP- and non-GMP technical documentation such as batch records, work instructions, 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.

Plan and execute technology innovation and improvement projects as well as optimizing pilot lab operation efficiency.

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

Basic Qualifications:

Bachelor’s Degree with 6 years’ experience

OR

Master’s Degree with 4 years’ experience

OR

PhD/ PharmD

Preferred Qualifications:

Associate degree with 10+ or BA/BS with 6+ of relevant experience in biologics pilot plant/manufacturing operations .

Experience in biologics manufacturing equipment operations and single-use manufacturing technologies. Working knowledge in equipment automation and data management is a plus.

Hands-on experience in pilot scale media and buffer preparation, cell culture and/or purification unit operations.

Proven track records in pilot lab facility maintenance, raw material and consumable procurement and inventory management, equipment maintenance and troubleshooting. Experience in process transfer is a plus.

Experience in authoring and maintaining GLP batch records, BOMs, work instructions, guidance documents, production reports and pilot lab training program.

Excellent organization skills. Demonstrated ability to plan and coordinate pilot lab operation activities. Experience in mentoring and coaching junior staff is a plus.

Demonstrated experience in pilot lab operation efficiency…