Description:

• 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.

• The Specialist, Manufacturing role will ensure successful manufacture and release of cell therapy products by following established processes in full compliance with cGMP.

• This role also supports manufacturing operational readiness and the successful technology transfer of pipeline products using knowledge of cGMP regulations.

• Using general application of principles, 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.

• 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.

• CAR-T immunotherapy production operator/verifier/runner

• Deviation support

Qualification:

• 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.

• 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

• Working Hours: M-F 7-3:30pm and then should become Sun-wed 7-5:30pm

California Fair Chance Act:

Synectics Inc. will consider qualified applicants with a criminal history pursuant to the California Fair Chance Act. You do not need to disclose your criminal history or participate in a background check until a conditional job offer is made to you. After making a conditional offer and running a background check, if Synectics Inc. is concerned about conviction that is directly related to the job, you will be given the chance to explain the circumstances surrounding the conviction, provide mitigating evidence, or challenge the accuracy of the background report. Find out more about the Fair Chance Act by visiting calcivilrights.ca.gov/fair-chance-act/.

LA County Fair Chance Ordinance:

Background Check: In accordance with the LA County Fair Chance Ordinance, we will consider for employment all qualified applicants, including those with a criminal history, in a manner consistent with applicable law. Except as otherwise permissible under applicable laws, you will not be asked to provide information about a conviction history unless you receive a conditional offer of employment. Synectics will make an individualized assessment of whether your conviction history has a direct or adverse relationship with the specific duties of the job, and will also consider potential mitigating factors, including, but not limited to, evidence and extent of rehabilitation, recency of the offense(s), and age at the time of the offense(s). If asked to provide information about a conviction histo