CaseBioscience is a quality-driven cGMP manufacturer and formulator of advanced media and biopreservation solutions to serve and advance the fields of cell therapy, gene therapy and regenerative medicines. Our mission is to serve as a reliable and timely strategic partner to support research, pre-clinical and clinical activities through our custom manufacturing services and our innovative culture medium and biopreservation solutions.
General Summary and Purpose
- The Aseptic Technician is a core team member of the manufacturing team.
- The Aseptic Technician is responsible for daily production including environmental monitoring, formulating, and sterile filling of aseptic GMP manufactured products according to batch records and SOPs.
Duties and Responsibilities:
- Most of your job duties will be directly related to processes of formulation, filling, and packaging of Quality System regulated compliant media products. This includes but is not limited to:
- Working inside cleanroom suites on your feet for several hours at a time
- Disinfecting and transferring materials and equipment into the cleanroom for production
- Performing environmental monitoring
- Weighing, measuring, and checking raw materials to ensure batches manufactured contain proper ingredients and quantities.
- Aseptically filling solutions into finished product containers under sterile conditions
- Performing washing and disinfection of lab ware used in GMP manufacture.
- Performing cleaning of equipment and classified cleanrooms facility (ceiling, walls, critical surfaces, and floors)
- Performing repetitive tasks while gowned (hood, mask, coveralls, boots, gloves, etc.)
- Operating equipment such as balances, volumetric glassware, peristaltic pumps, filters, pH meter, and pipettes
- Performing all tasks while following all SOPs, batch records, and safety policies
- Accurately completing batch record documentation, all appropriate logbook entries, and GMP documentation
- 5-10% of job duties will include indirect manufacturing support projects. This includes but is not limited to:
- Performing preventive maintenance on manufacturing equipment following SOPs
- Performing tasks that contribute to process improvements.
- Other projects and duties as required.
- Required to be on-call for equipment monitoring on a rotation.
- Education Minimum: Two years of college-level biological coursework, i.e. in Chemistry, Biology, Physics, etc. or one-year experience working in a GMP Manufacturing setting is required.
- Experience Requirement Minimum: Prior aseptic gowning and processing techniques is desirable.
- Self-motivated and willing to accept temporary responsibilities outside of normal job duties
- Comfortable working in a fast-changing small company environment and able to adjust work load based on changing priorities
- Must not have unusual sensitivity to typical laboratory chemicals (i.e. sanitization agents)
- Must be able to perform fast paced operations and repeatedly perform multi-step simultaneous operations with a high degree of accuracy
- Effectively communicate while wearing cleanroom gowning (mask, hood, coveralls, gloves, etc.)
- Must be able to work effectively in a group and independently
- Must be able to meet aseptic gowning qualification requirements
- Must be able to work regularly with cleaners
- May be required to work either day or evening shift as needed
- May occasionally be required to work weekends and overtime as needed
CaseBioscience is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.