Sr. Process Engineer – Cell Therapy (Hybrid- Seattle, WA)

We are looking for a Sr. Process Engineer – Cell Therapy (Hybrid- Seattle, WA) for a global pharmaceutical company. 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 lead 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.

This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite role in Seattle, WA

This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.

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.
• 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. Share operational and process leanings with the rest of the manufacturing network
  
  

Requirements

• 5 years of experience in the Biotech industry. Experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products and cGMPs, is preferred.
• Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products.
• Life Cycle Management Experience
• Extensive experience with change control processes, document approvals, and the management of Standard Operating Procedures (SOPs), Work Instructions (WIs), deviations, and Corrective and Preventive Actions (CAPAs) within a quality management system.
• Experience developing and implementing process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
• 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.
• Bachelor’s or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences.
  
  

Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Sr. Process Engineer – Cell Therapy (Hybrid- Seattle, WA) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $60/hr - $69.93/hr.