Description:
Bioprocess Associate 2, you'll be executing established upstream production processes in a cGMP environment, as well as contributing to the planning and procurement for future productions. We need someone with strong hands-on cell culture skills, disciplined documentation habits, and the ability to work both independently and in a group, within defined procedures.
Core Responsibilities:
- Perform upstream bioprocess workflows, including mammalian cell culture maintenance, per established protocols and cGMP standards
- Support and occasionally participate in downstream bioprocess workflows such as but not limited to basic supply preparations, formulations, and documentation
- Operate production equipment (pipettors, balances, biosafety cabinets, incubators, autoclaves, microscopes, centrifuges) accurately and safely
- Complete manual, cGDP-compliant documentation in batch records and forms with a high degree of accuracy
- Coordinate bioprocessing supply needs (e.g. raw material sourcing/pricing) and assist with planning for future productions.
- Collaborate with Process Development Team on technical transfer and experiment needs
- Contribute to the editing/updating of controlled process documentation as needed
- Mentor, train, and review the work and documentation of junior team members as needed
Required Skills and Experience:
- Bachelor's degree in a relevant field (e.g. biology, cell biology, biochemistry, bioengineering) with 3+ years of directly relevant experience
- Significant, hands-on experience with aseptic mammalian cell culture techniques
- Broad working knowledge of stem cell culture processes
- Excellent organizational and communication skills, and the ability to manage substantial technical data, multiple priorities, and competing deadlines
- Strong attention to detail and document review skills to reliably produce audit-ready process documentation
- Proficiency with primary Microsoft Office Suite tools (Outlook, Microsoft Word, PowerPoint, Excel)
- Ability to work cooperatively in a controlled environment (ISO 5, 7, and 8) wearing clean room PPE for extended periods of time.
- Willingness to participate in a rotating weekend work and holiday schedule to perform primary cell culture maintenance tasks