Manufacturing Operator

Position Summary
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 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.

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.

Job Types: Full-time, Contract

Pay: $25.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Application Question(s):

• Please confirm your email address and contact number.

Education:

• Bachelor's (Preferred)

Experience:

• cGMP process: 1 year (Preferred)
• CMC regulatory framework for biologics: 1 year (Preferred)
• GMP manufacturing: 5 years (Preferred)
• GMP clinical/commercial manufacturing operations: 1 year (Preferred)
• cell therapy manufacturing: 5 years (Preferred)
• Standard Operating Procedures (SOPs): 1 year (Preferred)

Work Location: In person

Salary : $25