Process Engineer

Bristol Myers Squibb; Seattle (WA); Hybrid; USD 75,850 - 96,335; Full time

Job summary

A leading biotechnology company in Seattle seeks a Senior Engineer for Cell Therapy Technical Operations. The role involves managing the lifecycle of CAR-T therapy and collaborating across all manufacturing sites. Responsibilities include leading commercial lifecycle plans, developing process improvement projects, and providing technical content for regulatory submissions. Ideal candidates have a degree in Chemical or Biomedical Engineering, at least 5 years' experience in biotech, and proficiency in data management tools. The position offers competitive hourly compensation and a hybrid work model.

Qualifications

• More than 5 years of experience in the Biotech industry.
• Experience in a self-driven, fast-paced matrix environment.
• Detail-oriented with excellent communication skills.

Responsibilities

• Lead the commercial lifecycle plan for a cellular product.
• Develop and implement process improvement projects.
• Provide technical content for significant documents.

Skills

Life Cycle Management Experience

Data management/statistical analysis software proficiency

Problem-solving skills

Ability to work in cross-functional teams

Education

Bachelors or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences

Tools

Excel

JMP

Spotfire

Job description

Hybrid

Hybrid: 50%+ days onsite required, days of week are flexible

Job Description

Top Skills:

• Life Cycle Management Experience.
• Experience developing and implementing process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
• Familiarity with cell therapy processes and camps.
• Experience assimilating large data sets in support of batch history sections for regulatory submissions.
• Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.

Position Summary

Cell Therapy Technical Operations (CTTO) is responsible for global product lifecycle strategy and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product lifecycle. The Senior Engineer will be responsible for the implementation of cell therapy manufacturing technologies, and process changes related to the life‑cycle management of a commercial CAR‑T Therapy. This includes establishing the strategy for process changes, coordinating technical alignment, and leading implementation at a global level. This role collaborates across all CMC functional areas and drug product manufacturing sites to ensure project advancement, rapid and best‑in‑class execution, and communication of challenges/opportunities. The candidate will help drive the validation, qualification, and comparability strategies.

Duties/Responsibilities

• Lead the commercial lifecycle plan for a cellular product, maintain oversight of process capability through data trending and statistical analysis of critical variables, ensure processes are robust, in a continued state of validation, and continuously improving.
• Develop and implement process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
• Develop product technical strategies including manufacturing requirements, process improvement plans, and ensure successful and timely execution working across functional groups.
• Provide technical content for significant documents such as validation activities, author content for regulatory submissions.
• Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions.
• Provide necessary technical analysis to support impact assessments and investigations.
• Function as a subject matter expert for autologous T‑cell therapies and manufacturing technologies.
• Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
• Present complex technical topics internally and externally.
• Share operational and process leanings with the rest of the manufacturing network.

Qualifications

• Bachelors or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences with more than 5 years of experience in Biotech industry. Familiarity with cell therapy processes and camps is preferred.
• Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Experience assimilating large data sets in support of batch history sections for regulatory submissions. Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.
• Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
• Ability to assess risk and develop contingency plans for process risks.
• Able to manage time and elevate relevant issues to project lead and line management.
• Detail oriented with excellent verbal and written communication skills.
• Strong interpersonal and leadership skills to work with teams in different functions and organizations.

Compensation

The starting hourly compensation for this assignment is within the range of $55.06 - $69.93/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not client). Factors influencing this decision may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job. Compensation details are subject to change.

Seniority level: Mid‑Senior level

Employment type: Contract