The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Process Engineer in Princeton, NJ/Hybrid.

Role Description

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

Skills & Requirements

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

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 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.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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