Senior Process Engineer I, Viral Vector Process Design

Senior Process Engineer I, Viral Vector Process Design

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

Job Description

Kite is seeking a highly motivated Senior Process Engineer I to be an integral member of the viral vector process development team to design and characterize viral vector processes at Kite. The candidate will contribute to process development and engineering activities required to enable robust GMP manufacturing of viral vectors to support Kite’s early and late phase pipeline programs. The primary responsibilities will be to identify opportunities for process improvements, design, implement, and lead lab-based activities to mitigate risks in GMP manufacturing. The candidate is expected to interface between various Technical Operations groups (analytical development, manufacturing science and technologies (MSAT), manufacturing, supply chain, quality, technology transfer, T-cell process design) and effectively communicate study outcomes and program timeline risks along with mitigations. The Senior Process Engineer I will be an exceptional communicator, critical thinker, and will have proven effectiveness at matrix influencing in an exciting environment.

Responsibilities include, but are not limited to:

• Design, implement and lead lab-based activities supporting process improvement studies and life cycle development.
• Support lab implementation and develop a best practices and proactive safety culture amongst PDe staff.
• Collaborate with Operations, Manufacturing, Autologous PDe, and MSAT teams to identify process improvement needs and develop a strategy encompassing feasibility evaluation through implementation for next generation platform processes.
• Design, implement and analyze process characterization studies in support of late phase programs.
• Provide hands-on training of viral vector unit operations to vPDe, MSAT and manufacturing staff.
• Become a subject matter expert of vector product and process platform historical data in order to propose process design improvements that can resolve program risks.
• Effectively communicate process data trends, characterization results and process improvements in both written and presentation format, while working collaboratively between Process Design, Manufacturing, MSAT, and Quality.
• The candidate should be able to make key insights to data and develop solutions (i.e. root cause identification or corrective and preventative actions (CAPAs)) in a collaborative multidisciplinary environment.
• Authoring of and/or reviewing of technical documentation to enable technology transfer from process development to GMP manufacturing facilities as well as regulatory filing submissions.

Basic Requirements:

• MS/MA Degree in Chemical/Biochemical Engineering, Biomedical Engineering, Biotechnology or a related discipline and 4+ years of pharmaceutical/biotech industry experience in manufacturing or process development as well as sustained excellence in performance and accomplishments that align to company goals or
• BS/BA Degree in Chemical/Biochemical Engineering, Biomedical Engineering, Biotechnology, or a related discipline with 6+ years of pharmaceutical/biotech industry experience in manufacturing or process development or
• High School Diploma with 11+ years of pharmaceutical/biotech industry experience in manufacturing or process development.

Preferred Requirements:

• Practical expertise/knowledge of cGMP manufacturing for Biologics or Viral Vector or Gene and Cell therapy products.
• Exceptional written and oral communication skills to a scientific and quality-focused audience.
• Experience in managing multiple complex projects simultaneously through effective time management and with little oversight.
• Previous experience with process design and technology transfer is preferred. Knowledge of process validation and qualification is preferred.
• Thorough understanding of operating and performance parameters, as well as establishing parameter ranges.
• Previous experience with cell culture and aseptic process experience is preferred.
• Previous experience with downstream purification operations inclusive of depth filtration, ultrafiltration/diafiltration, chromatography, and sterile filtration preferred.
• Previous experience with final fill into bags or vials preferred.
• Working knowledge of scientific and engineering principles.
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills based on deductive reasoning.
• Comfortable in an exciting, small company environment with minimal direction and able to adjust workload based upon changing priorities.
• Self-motivated and willing to accept temporary responsibilities outside of initial job description.
• The role is site-based with primary location in Santa Monica, but need ability to travel, based on business priorities.
• Ability to consistently demonstrate company core values of Excellence, Integrity, Inclusion, Accountability and Teamwork.
• The ability to work effectively in a diverse, inclusive environment.

The salary range for this position is: $130,220.00 - $168,520.00. 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