Manufacturing Specialist

Position Summary

We are seeking a Manufacturing Specialist to support our dynamic Manufacturing team in the production of TCR-T, CAR-T, and allogeneic cell therapy investigational products. This contract role is based in Tarzana, CA, with occasional travel to Santa Monica, CA as needed. Role will ensure successful manufacture and release of cell therapy products by following established processes in full compliance with cGMP.

Responsibilities

• Support manufacturing operational readiness and the successful technology transfer of pipeline products using knowledge of cGMP regulations.
• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Avoidance of contamination and adherence to aseptic techniques for primary human cell cultures and GMP manufacturing.
• Support Manufacturing Science and Technologies (MS&T) to align manufacturing plans with MS&T plans.
• Ensure that all production operations are controlled and performed within cGMP regulatory guidelines.
• Provide verbal and written updates to Manufacturing leadership.
• Perform other responsibilities and project-based assignments as needed to support manufacturing operations.

Qualifications

• Minimum of five (5) years of experience with a High School Diploma or a BS/BA in a relevant science or engineering discipline.
• Understanding of cGMP process and knowledge of CMC regulatory framework for biologics.
• Knowledge of aseptic techniques for primary human cell cultures and GMP manufacturing and supporting tech transfer and GMP clinical/commercial manufacturing operations.
• Knowledge of industry practices, cell therapy manufacturing experience preferred.
• Develop solutions to complex problems independently.
• Help determine goals of assignment.
• Plan schedules and arranges own activities.

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 of the month following at least 1 calendar year after employment begins.