Position Summary: Work in a team based environment to perform all tasks related to the production and qualification of cellular based products for use in research and commercial products for use in the life sciences industry. The hours for this role will be predominantly business hours. Flexibility to fit production requirements will be necessary.
Key Objectives of the role:
- Responsible for manufacturing product(s) in a lab setting following standard operating procedures. Will utilize basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products.
- Will perform media and solution preparation, maintain cell lines, small scale roller bottles and shake flask production, large scale bioreactor production, cell harvest, and conduct cellular based assays while utilizing aseptic techniques.
- Responsible for Batch Data Records, notebooks, customer reports and work order documents.
- Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating parameters. Advise manager of factors that may affect quality of product
- Verbal or written communication of problems to manufacturing leadership and assistance in identifying variables and offering resolutions
- Maintain equipment, product inventories and related records as assigned. Complete, distribute and file records as required in accordance with Document Control Practices.
- Interact daily with equivalent levels of personnel in the manufacturing area
- Attend trainings or read content to understand and follow applicable manufacturing processes and Standard Operating Procedures
- May train other team members on techniques and processes
- All other reasonable tasks as may be requested by the Team Leader and/or the Production Supervisor.
- May perform other related duties as required and/or assigned.
Minimum Qualifications (must have):
- Must have a bachelor’s degree in Biology, Chemistry, Biochemistry, or other related discipline.
- Requires a minimum of 1-3 years relevant experience demonstrating laboratory techniques in a manufacturing environment or research laboratory.
- Demonstrated proficiency in the use of scientific laboratory techniques, equipment and materials required. Experience in the use of basic laboratory techniques, including media and solution preparation, cell expansion, transfection, maintaining cell lines, antibody production, and cellular assays.
- Familiar with wave bioreactor operation and harvest.
- Experience with mammalian cell lines
- Lifting up to 20 lbs will be required on a frequent basis.
- May be required to stand for long periods of time while performing duties.
- Must be flexible to work varying schedules and hours as needed.
- Must be able to work safely with chemicals and hazardous materials.
- Consistent, dependable and accurate in carrying out responsibilities
- Excellent documentation and communication skills
Preferred Qualifications (nice to have):
- Experience with Good Documentation Practices
- Experience in ISO or cGMP regulated manufacturing environment.
- Working knowledge of Microsoft Excel and MS Word
- Working knowledge of MRP system.
This position has not been approved for Relocation Assistance.