Job Description
Job Description
Job Description:
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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.
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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.
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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.
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Help drive the validation, qualification, and comparability strategies.
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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.
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Develop and implement process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
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Develop product technical strategies including manufacturing requirements, process improvement plans, and ensure successful and timely execution working across functional groups.
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Provide technical content for significant documents such as validation activities, author content for regulatory submissions.
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Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions.
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Provide necessary technical analysis to support impact assessments and investigations.
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Function as a subject matter expert for autologous T-cell therapies and manufacturing technologies.
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Provide technical input and requirements for design of future clinical and commercial manufacturing facilities.
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Present complex technical topics internally and externally.
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Share operational and process leanings with the rest of the manufacturing network
Qualifications
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Bachelor's or Graduate degree in Chemical Engineering, Biomedical Engineering or Life Sciences with more than 5 years of experience in Biotech industry.
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Ability to effectively work in cross functional teams, meet deadlines as an individual contributor, and prioritize responsibilities.
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Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
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Experience assimilating large data sets in support of batch history sections for regulatory submissions.
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Proficiency in data management/statistical analysis software, including Excel, JMP, and Spotfire is preferred.
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Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs.
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Ability to assess risk and develop contingency plans for process risks
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Able to manage time and elevate relevant issues to project lead and line management.
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Detail oriented with excellent verbal and written communication skills.
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Strong interpersonal and leadership skills to work with teams in different functions and organizations
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Proven ability to lead and drive projects within cross-functional teams, ensuring alignment and collaboration across multiple departments and organizations.
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A proactive and independent thinker.
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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.
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Hands-on experience in the cell therapy field, particularly with CAR-T (Chimeric Antigen Receptor T-cell) products.
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Ability to build strong relationships and a positive reputation with various teams and stakeholders.
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Life Cycle Management Experience
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Experience developing and implementing process improvement projects to improve robustness, scalability, and Cost of Goods (COGs) for cell therapy products.
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Familiarity with cell therapy processes and cGMPs
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.