Gilead Sciences · 2 days ago
Associate Director, Process Development
United States - California - Santa Monica
Full-time
Onsite
Lead/Staff, Director/Executive
$178K/yr - $230K/yr
5+ years expGilead Sciences is dedicated to curing cancer through innovative therapies. The Associate Director, Process Development will lead a team in life-cycle management for cell therapy products, focusing on process characterization, regulatory compliance, and business process improvements.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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
Qualification
Required
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
Preferred
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
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-23
GlobeNewswire
2026-01-22
Company data provided by crunchbase