Manufacturing Associate
Manufacturing Associate
Harba Solutions Inc.
Greater Boston
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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.
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Seniority level
Associate -
Employment type
Full-time -
Job function
Manufacturing, Quality Assurance, and Science -
Industries
Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing
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Medical insurance -
Dental insurance -
Vision insurance -
401(k)
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