Gilead Sciences · 11 hours ago
Sr Process Engineer I
United States - California - Santa Monica
Full-time
Hybrid
Mid, Senior Level
$133K/yr - $172K/yr
4+ years expGilead Sciences, through its subsidiary Kite Pharma, is dedicated to curing cancer with innovative therapies. They are seeking a Senior Process Engineer I to lead process development and technology activities, ensuring compliance with quality and GMP standards while collaborating across teams to enhance supply chain resiliency.
BiotechnologyHealthcarePharmaceuticalManufacturingBiopharmaHealth Care
Responsibilities
Lead and coordinate hands-on process development (PD) and technology development activities, including laboratory study design, experimental execution, analytical sampling plans, and data interpretation
Communicate study outcomes to cross-functional partners and risk assessment teams to support data-driven decisions
Define raw material requirements, qualification strategies, and acceptance criteria to support technology transfer, commercial launch, and product lifecycle management
Translate process, quality, and GMP requirements into clear design and technical specifications for vendors and external partners
Perform Supplier Notification Assessments (SNAs), global project-related raw material change assessments, and raw material deviation impact assessments
Develop, implement, and maintain Raw Material Lifecycle Management (LCM) strategies
Drive second-source raw material initiatives and collaborate with internal stakeholders to improve supply chain robustness and resiliency
Lead and support Material FMEA, Container Closure Integrity Testing (CCIT), Adventitious Agent, and Nitrosamine risk assessments in support of regulatory filings
Support deviation investigations, supplier audits, and regulatory inspection responses related to raw materials and consumables
Qualification
Required
BS in a related discipline with at least 6 years of experience in pharmaceutical or biotechnology process development
OR
MS in a related discipline with at least 4 years of experience in pharmaceutical or biotechnology process development
Lead and coordinate hands-on process development (PD) and technology development activities, including laboratory study design, experimental execution, analytical sampling plans, and data interpretation
Communicate study outcomes to cross-functional partners and risk assessment teams to support data-driven decisions
Define raw material requirements, qualification strategies, and acceptance criteria to support technology transfer, commercial launch, and product lifecycle management
Translate process, quality, and GMP requirements into clear design and technical specifications for vendors and external partners
Perform Supplier Notification Assessments (SNAs), global project-related raw material change assessments, and raw material deviation impact assessments
Develop, implement, and maintain Raw Material Lifecycle Management (LCM) strategies
Drive second-source raw material initiatives and collaborate with internal stakeholders to improve supply chain robustness and resiliency
Lead and support Material FMEA, Container Closure Integrity Testing (CCIT), Adventitious Agent, and Nitrosamine risk assessments in support of regulatory filings
Support deviation investigations, supplier audits, and regulatory inspection responses related to raw materials and consumables
Strong computer skills with the ability to multitask, self-organize, and manage competing priorities
Demonstrated project management experience, including cross-functional coordination
Self-motivated, accountable, and willing to take on responsibilities outside the initial scope as business needs evolve
Collaborative, results-oriented mindset with a positive attitude and resilience in overcoming technical and operational challenges
Ability to thrive in a fast-paced environment with minimal direction and adapt quickly to changing priorities
Preferred
PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biochemistry, Materials Science, or a related discipline
Familiarity with regulatory requirements applicable to pharmaceuticals and single-use disposable systems
Hands-on experience with cell culture techniques, including bioreactors, cell isolation, and use of standard laboratory equipment
Experience in aseptic processing, cell passaging, sampling, media formulation, reagent and vial management, and cryopreservation
Proficiency in statistical design of experiments (DoE) and data-driven process optimization
Strong scientific and engineering foundation in bioprocessing, scale-up/scale-out, hydrodynamics, mass transfer, and equipment design and control
Understanding of cell biology principles, including differentiation, phenotype markers, and metabolic pathways (preferred)
Working knowledge of materials science, material compatibility, and interactions with cell culture systems (preferred)
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives
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
2026-02-12
2026-02-12
Company data provided by crunchbase