Job Description

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!

Kite is seeking a highly motivated individual with biotechnology experience to work on innovative T-cell therapies for cancer treatment. As a Sr. Process Engineer I in Global Process Engineering (GPE) group, you will have a key global role within Kite's Process Development and Technical Operations functions to by providing technical leadership for global process engineering initiatives, technology evaluation, equipment and/or facility design and seek to align standards and approaches across Kite’s engineered autologous T cell therapy products and viral vector sites. Lastly, the Incumbent will work with the Process Design, Manufacturing and Quality teams to implement cell therapy processes to multiple sites, establish novel technology and equipment qualification strategies and lead all aspects of process engineering, as well as documentation for user requirements, designs and standards.

Responsibilities:

• Lead, develop and apply sound scientific and engineering principles to align requirements, standards and approaches across the global network.
• Support lifecycle management of activities including troubleshooting process equipment, support the evaluation of process equipment changes either supplier-initiated change (SIC) or change control, and ensure technology readiness for introduction into commercial GMP manufacturing.
• Provide technical support for equipment qualification standards, framework for harmonized risk-based qualification strategies for similar equipment and unit operations across plants and alignment of PQ activity with process and operational requirements
• Based on product and process lifecycle requirements, define and establish sound scientific approaches for risk evaluation of global process change impact on process and equipment.
• Interface internally with process design, analytical development, technical development, Global/Site MSAT and process technical Leads and cross-functionally with Quality, Manufacturing and Engineering to implement new processes and technology as part of technology transfers.
• Provide key technical liaison between Operations, Technology, PD and the vendors of new automated technologies to reduce COGM and ensure manufacturing robustness without sacrificing quality
• Work with vendors and suppliers to define requirements and understand functional specifications
• Support investigation, identify root cause for critical deviations during cGMP and resolve CAPAs for manufacturing
• Write, Review/Approve user documentation such as validation master plans, protocols reports for FATs, SATs, IQ/OQ/PQ testing, comparability, aseptic process and cell therapy manufacturing process validation testing in alignment with Kite Global SOPs

Requirements:

• MA/MS/MBA degree in Statistics, Biochemical Engineering, Biotechnology or Life Sciences with 4+ years of pharmaceutical manufacturing, process development or process engineering experience; OR
• BA/BS degree in Statistics, Biochemical Engineering, Biotechnology or Life Sciences with 7+ years of pharmaceutical manufacturing, process development or process engineering experience

Additional Qualifications:

• Experience in and an excellent understanding of process equipment and engineering, technology transfer or pharmaceutical manufacturing experience
• Cell culture, cell therapy or aseptic processing experience
• Equipment and/or new technology design, qualification and testing experience in a cGMP environment (IQ, OQ, PQ) including process validation
• Self-motivated, excellent prioritization, and risk management skills
• Ability to think critically, and demonstrated problem-solving and investigation skills
• Excellent interpersonal, verbal and written communication skills as well as digital literacy
• Ability to function efficiently and independently in a changing environment
• Ability to share complex principles of knowledge with others (team member, stakeholder, external, or inspection) and create understanding along with excellent technical writing abilities
• Team player with excellent 360-degree communication skills
• Proactive and willing to accept temporary responsibilities outside of initial job description
• Experience leading cross functional teams and stakeholder management to obtain project deliverables is a plus

The salary range for this position is: $117,725.00 - $152,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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