Manufacturing Associate

Job Responsibilities:

• Assist in the setup, operation, and maintenance of cell therapy manufacturing equipment.
• Execute manufacturing processes in accordance with standard operating procedures (SOPs) and batch records.
• Perform aseptic techniques in a cleanroom environment to ensure the sterility of cell therapy products.
• Conduct routine in-process quality checks and inspections to ensure products meet quality standards.
• Document all production activities accurately and promptly in electronic batch records (EBR) and other required documentation.
• Participate in troubleshooting and resolving production issues as they arise.
• Collaborate with the process development team to implement process improvements and optimize manufacturing workflows.
• Assist in the transfer and scale-up of new cell therapy processes from development to manufacturing.
• Adhere to all GMP (Good Manufacturing Practice) guidelines and regulatory requirements.
• Participate in safety training programs and contribute to maintaining a safe working environment.
• Ensure all manufacturing activities comply with company policies and procedures.

Qualifications:

• High School Diploma or AS/BS degree in Biology, Biochemistry, Molecular Biology or relevant field.
• 1-4 years of experience in a cell therapy or biopharmaceutical manufacturing environment is desirable.
• Experience working in a GMP-regulated environment is a plus.
• Proficiency in aseptic techniques and working in a cleanroom environment.
• Strong attention to detail and commitment to quality.
• Ability to follow detailed written and verbal instructions accurately.
• Excellent organizational and time management skills.
• Strong communication skills and ability to work effectively in a team.
• Familiarity with cell culture techniques and related laboratory equipment.
• Basic computer skills, including proficiency with MS Office (Word, Excel).
• Ability to lift and carry up to 25 pounds.
• Ability to work standing for extended periods and perform repetitive tasks.
• Good manual dexterity and visual acuity.