Associate Director, Process Development

Associate Director, Process Development

United States - California - Santa Monica Process/Product Development & Operations Regular

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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 Kite and help create more tomorrows.

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

Kite is seeking a strong candidate for the role of Associate Director in life-cycle management team for Kite’s commercialized cell therapy products. This individual will be based within process design and will lead a team that enables process characterization & post‑commercialization changes to manufacturing process, through feasibility assessments, characterization studies, support of process validation, regulatory filings, GMP manufacturing, response to agencies and pre‑approval inspections for commercial sites.

In addition, this role will also lead business process improvements within life‑cycle management as it pertains to implementation of novel process improvements utilizing QbD principles and incorporation of automation using AI machine learning models for process characterization and development. This role is expected to routinely interface and maintain good work relationships with several key stakeholders within the company including but not limited to analytical sciences, manufacturing sciences and technology, commercial manufacturing, quality, and CMC product teams.

• Work with key stakeholders to support the life‑cycle management activities including developing efficient business processes for process characterization and development of integrated control strategies.
• Provide guidance to team members to enable efficient and timely execution of life‑cycle management activities.
• Act as an SME for design of experiments, execution of studies under protocol, appropriate use of statistical approaches, implementation of QbD principles, authoring of reports / regulatory documents, response to questions from regulatory agencies, process data analysis & trading using JMP, and GMP manufacturing support.
• Review technical documentation, technical SOPs, manufacturing batch records, technical reports and summary reports.
• Support equipment qualification, risk assessment, process characterization, parameter classification TT and process validation activities for commercial manufacturing.
• Support and lead AI initiatives for process development and characterization.

• PhD Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 5+ years of experience.
• MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 8+ years of experience.
• BS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with…