Manufacturing Specialist

Seeking a Contract 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.

• Ensure successful manufacture and release of cell therapy products by following established processes in full compliance with cGMP.
• Support manufacturing operational readiness and successful technology transfer of pipeline products using knowledge of cGMP regulations.
• Support activities to ensure GMP readiness for clinical manufacturing, including but not limited to equipment procurement, installation and qualification, facility qualification, and technology transfer.
• Perform operational tasks within a cleanroom environment in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Assist in developing Standard Operating Procedures (SOPs) and other documents for manufacturing processes.
• Set up manufacturing areas and equipment, including complex automated cell processing equipment.
• Follow all cleaning and gowning procedures for the facility.
• Maintain appropriate inventories of material and supplies within the cleanroom areas to support manufacturing activities.
• Ensure all materials and equipment are identified and available in time for manufacturing activities.
• Support Process Development (PD) and Manufacturing Sciences & Technology (MSAT) to align manufacturing plans with product development 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.
• Working Hours:
  
  M-F 8 Hours; subject to change to 4x10's shift on either Sun‑Wed. or Wed‑Sat.

• Minimum of five (5) years of experience with a High School Diploma; OR
• 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.
• Refer to established precedents and policies or use original thinking.
• Help determine goals of assignment.
• Plan schedules and arranges own activities.
• Work is reviewed upon completion for adequacy in meeting goals.
• CAR‑T immunotherapy production operator/verifier/runner.
• Deviation support.
• Experience with operating cell therapy equipment such as NC‑200 Nucleocounter Automated Cell Counter, Dynasellect, Cue, Welder, Sealer, Microscope, Sefia, Finia, Sepax, and ISO 5 aseptic operations.

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through Blue Cross Blue Shield 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 Met Life. 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.