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Production Operator

eTeam Inc.

Tarzana, CA

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JOB DETAILS
SALARY
$23–$24 Per Hour
SKILLS
Asepsis, Budgeting, Calendar Management, Cell Cultures, Cleanroom, Contract Management, Contract Manufacturing, Current Good Manufacturing Practice (cGMP), GMP (Good Manufacturing Practices), High School Diploma, ISO (International Organization for Standardization), Inventory Management, Investigational New Drug (IND), Leadership, Manufacturing, Manufacturing Operations, Manufacturing/Industrial Processes, Medical Products, Operational Support, Policy Development, Process Development, Product Development, Product Planning, Production Control, Purchasing/Procurement, Quality System Requirements (QSR), Recruiting/Staffing Agency, Regulations, Safety/Work Safety, Standard Operating Procedures (SOP), Standards Development, Technical Support, Welding, Willing to Travel
LOCATION
Tarzana, CA
POSTED
1 day ago
Job Title: Production Operator
Location: Tarzana Ca
Duration: 3 Months
Working Hours: M-F 8 Hours; subject to change to 4x10s shift on either Sun.-Wed. or Wed.-Sat.

Working Hours/Schedule:
The first 30-60 days require training and is based on the training schedule. Typically 9am-5pm, with the potential for an earlier start on some days.

Interview Process:
30 minutes via MS Teams

Position Summary
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 contract role is based in Tarzana, CA, with occasional travel to Santa Monica, CA as needed. The contractor will report to the Associate Director of Manufacturing, NGF70.
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.
This is a 90 day contingent assignment, with the possibility of extension based on project needs, performance, and budget availability.
Compensation and employment terms will be managed through an approved staffing partner. This role is not eligible for company-sponsored benefits unless provided by the staffing agency.

Responsibilities
" 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.

Experience and Education
" 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 CClient 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.

Additional Requirements
" 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

When we put unexpected teams in the same room, we fuel bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

About the Company

e

eTeam Inc.

Looking for a great job? Join eTeam. We’re looking for talented staffing professionals to join our staff. We also provide contract assignments and full-time jobs at Fortune 2000 Companies. We’ve been named one of the best companies to work for by Staffing Industry Analysts and New Jersey Business.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Other/Not Classified
FOUNDED
1998
WEBSITE
www.eteaminc.com

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