Contract Manufacturing Specialist

Job Description

Job Description

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.

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.

• 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

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 history, any convictions or court records which are exempted by a valid court order do not have to be disclosed.

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.

Synectics is an equal opportunity employer.

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities

Company Description

Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities