The Manufacturing Associate will execute activities associated with cell culture manufacturing in a clean room environment. Processes will be focused on viral vector based cancer vaccine products. This role will also need to assist with aseptic filling and buffer prep processes as well as maintain material inventory in labs.
Summary of essential job functions
- Must be able to work an 8 hour shift, 5 days per week including at least 1 weekend day each week (Sun-Thurs or Tues-Sat).
- Possess experience in cGMP manufacturing environment.
- Possess experience in mammalian cell culture, thawing cells, passaging cultures, counting cells, and transfection.
- Possess experience maintaining cell lines in small to medium scale bioreactors.
- Responsible for scheduling day to day activities and planning monthly work load for team.
- Responsible for day to day upstream (mammalian cell culture) manufacturing activities as well as stocking of materials, preparation of documentation, cleaning and sanitization of parts, rooms and equipment, operation of process equipment.
- Responsible for training new hires and maintaining up-to-date on-the-job training for current staff.
- Ability to document activities in accordance with cGMPs.
- Follow accurate verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
- Maintain cleanliness and orderliness of operational area
- Ability to identify process and quality problems and follow corrective actions
- Demonstrate knowledge and understanding of GMPs and how they apply to specific responsibilities
- Maintain a safe working environment
- Follow company policies and procedures
The ideal candidate for this position will have demonstrated experience with cell culture in GMP manufacturing within a cleanroom environment.
- BS in Biological Sciences or related scientific discipline
- 4+ years in a cGMP manufacturing environment
- Must possess leadership experience
- Must be able to pass aseptic gowning and aseptic processing qualification and have ability to work in cleanroom for up to 8 hours a day.
- Must be able to execute process steps according to defined SOPs and batch records.
- Knowledge of GMP and regulatory requirements preferred
- Experience in lean manufacturing, continuous improvement, Kaizen, 5S a plus.
- Experience with plasmid production a plus
- Manual dexterity
- Ability to lift items up to 50 lbs
- Standing for long periods of time
- Strong organizational skills and attention to detail
- Able to work effectively in a fast-paced, small start-up company environment.
- Self-motivated, self-disciplined and able to function independently as well as part of a team.
- Strong critical and logical thinking with ability to analyze problems
- Strong ability to prioritize, multi-task, and work in an evolving environment
- Excellent written and verbal communication skills.