Production Operator

About the role

We are 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 role ensures successful manufacture and release of cell therapy products by following established processes in full compliance with cGMP. The Specialist also supports manufacturing operational readiness and the successful technology transfer of pipeline products using knowledge of cGMP regulations.

Responsibilities

• Support activities to ensure GMP readiness for clinical manufacturing, including 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.
• Develop solutions to complex problems independently, referring to established precedents, policies, or original thinking.
• Help determine goals of assignment and plan schedules and arrange own activities.
• Act as a CAR-T immunotherapy production operator/verifier/runner.
• Provide deviation support.

Requirements

• 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.
• Experience supporting tech transfer and GMP clinical/commercial manufacturing operations.
• Knowledge of industry practices; cell therapy manufacturing experience preferred.
• 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.

Schedule

Working hours: Monday–Friday, 7:00 AM–3:30 PM, transitioning to Sunday–Wednesday, 7:00 AM–5:30 PM.

Benefits

• Healthcare Insurance: Eligible employees and their dependents receive 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. Premiums are subsidized by Synectics.
• Dental Insurance: Eligible employees and their dependents receive a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• Vision Insurance: Eligible employees receive vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment.
• 401(k) Plan: Synectics offers all employees aged 21 or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year of employment.