Associate Director, Process Development
米国 - カリフォルニア - サンタモニカ製品開発・オペレーション正社員仕事内容
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.
As an Associate Director, Process Development, at Gilead you will ...
Key Responsibilities:
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 & trending 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
Basic Qualifications:
PhD Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 5+ years of experience or
MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 8+ years of experience or
BS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 10+ years of experience or
Additional Qualifications:
Candidates with prior experience and demonstrated capability within life-cycle management of cell and gene therapy products will be preferred.
Candidates with prior leadership experience managing direct reports or cross-functional project teams will be preferred
Practical knowledge of regulations and requirements pertaining to cGMP manufacturing for cell and gene therapy products.
Practical knowledge of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches, and process data analysis including machine learning models for process development
Ability to think critically, troubleshoot, and problem solve in a timely manner.
Excellent interpersonal, verbal and written communication skills.
Ability to work and collaborate in a fast paced, dynamic cross-functional team setting across research, development, and manufacturing departments.
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.