MSAT Process Engineer

Dexian; Seattle (WA); Hybrid; USD 100,000 - 125,000; Full time

Job summary

A leading provider of staffing solutions is seeking a Senior Engineer specializing in Cell Therapy for a hybrid role in Seattle. The candidate will drive the execution and strategy for CAR-T Manufacturing processes, focusing on technical implementation and process improvements. The ideal candidate has a strong background in Chemical Engineering or Life Sciences, with proven leadership skills and experience in the Biotech industry. This role promises to enhance your career within a cutting-edge field, working with cross-functional teams to deliver high-quality results.

Benefits

Flexible working hours

Professional development opportunities

Remote work options available

Qualifications

• 5+ years in the Biotech industry.
• Familiar with cGMPs and cell therapy processes.
• Strong problem-solving skills.

Responsibilities

• Lead lifecycle management of CAR-T Therapy.
• Develop and implement process improvement for cell therapies.
• Coordinate with functional groups and ensure timely execution.

Skills

Project Management

Interpersonal Skills

Statistical Analysis

Process Improvement

Data Management

Education

Bachelor's or Graduate degree in Chemical Engineering

Life Sciences

Tools

Excel

JMP

Spotfire

Job description

This range is provided by Dexian. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$65.00/hr - $69.00/hr

Direct message the job poster from Dexian

Months- 12+ Months (potential extension)

Location- Seattle, WA (hybrid)

Pay Range- $65-69/hr on W2 without any benefits

Top Skills Required-

• Proven ability to lead and drive projects within cross-functional teams, ensuring alignment and collaboration across multiple departments and organizations. Looking for a proactive and independent thinker.

• 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.

• Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products.

• Exceptional interpersonal and communication skills, with a demonstrated ability to build strong relationships and a positive reputation with various teams and stakeholders.

Top Skills:

• 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 cGMPs

• 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 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.

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

• Bachelor’s 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 cGMPs 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.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Research, Manufacturing, and Other

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