Manufacturing Associate (Contract)
We are seeking a highly motivated Manufacturing Associate with experience in cGMP manufacturing and cell culture. This individual will perform a variety of procedures in a manufacturing environment in compliance with cGMP regulations to manufacture cell therapy products for use in human clinical trials.
- Produce cell therapy products using undifferentiated human embryonic stem cells in accordance with the manufacturing procedures, SOPs, and approved protocols in cGMP manufacturing environment
- Prepare required reagents, solutions, and buffers according to SOPs and approved protocols
- Maintains aseptic clean room environments to comply with current Good Manufacturing Practices (cGMPs) and Standard Operating Procedures (SOPs)
- Keeps detailed documentation in compliance with SOPs and Good Documentation Practice
- Operate and maintain cell culture laboratory equipment for production; e.g. Biosafety cabinets, incubators, centrifuges etc.
- Maintain supplies and reagents inventories, and order as needed
- Write and/or revise SOPs, protocols, reports, and other required documentation
- Provide support for commissioning and validation activities in addition to other facility start-up activities, as needed
- Collaborate with cross-functional teams i.e., Quality, Facilities, Product Development, and Analytical Technologies
- Perform additional job related duties as required
- Bachelor/Associate Degree in Biology/Chemistry/Life Sciences or related field, or Biotech certificate.
- 2+ years relevant cGMP manufacturing experience in Pharmaceutical/Biotech industry is preferred
- Aseptic manufacturing experience is highly desired
- Mammalian cell culture experience is preferred
- Experience writing standard operating procedures and other cGMP documentation is preferred
- Experience writing investigation, deviation and change control documentation is preferred
- Ability to understand, apply, and evaluate basic biology and scientific principles as appropriate for the position
- Excellent organizational and multi-tasking skills, attention to detail, and the ability to adapt to changing priorities
- Ability to identify and elevate processing issues and support solutions
- Must be able to work weekends and holidays as required
- Excellent oral and written communications skills and a collegial personality
- Thrives and succeeds in a team-oriented environment
- Computer literacy including fluency with Microsoft Word, Excel, Outlook
- Participate at appropriate department meetings
- Ability to sit or stand for long periods of time, and ability to lift 25-30 lbs
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.