Join the Biologics Pilot Plant (BPP) Process Operations Team, a dynamic group within our research laboratories dedicated to the cutting-edge manufacture of clinical supplies. This role is a vital bridge between process development and GMP manufacturing, focusing on leading cell expansion unit operations for vaccines and biologics. You will work in a high-energy, matrixed environment, collaborating closely with facility engineering, quality, and safety teams to execute pilot-scale campaigns. This is an excellent opportunity for a self-motivated professional to gain cross-functional exposure to both upstream and downstream activities while ensuring the highest standards of regulatory compliance.
Responsibilities
- Lead Cell Expansion Operations: Direct manufacturing steps for mammalian, yeast, or bacterial cell expansion, including vial thaw, shake flasks, and cell stacks.
- Execute GMP Campaigns: Oversee all aspects of preparation, execution, and closeout for biologic and vaccine bulk clinical supply campaigns.
- Manage Equipment Systems: Operate and maintain single-use disposable systems and traditional stainless-steel bioreactors.
- Cross-Functional Support: Provide secondary support for downstream operations such as filtration, chromatography, homogenization, and centrifugation.
- Documentation & Compliance: Prepare and manage critical GMP documents, including Standard Operating Procedures (SOPs) and Batch Records.
- Technical Troubleshooting: Identify and resolve process unit operation issues in real-time to maintain production schedules.
- Team Leadership: Lead small, multi-disciplinary project teams to achieve tactical objectives and ensure clear communication across departments.
- Process Integration: Evaluate and integrate innovative technology and process equipment fits into existing pilot plant workflows.
- Operational Readiness: Perform production readiness activities, including equipment cleaning and steam sanitization (SIP).
Education
- Minimum Requirement: Bachelor’s or Master’s degree in Chemical Engineering, Biological Sciences, or a related technical field.
Experience
- Required: 1–3 years of relevant experience in GMP manufacturing or process development cell culture activities.
- Technical Skills: Working knowledge of cGMP, Quality Systems, and safety protocols for operations.
- Preferred: Experience leading small teams in a matrixed organization and a technical background in cell culture unit operations (incubation, harvest, vial filling, and freeze/thaw recovery).
Additional Information
- Schedule: This position requires the ability to work some overtime, including weekends and occasional second or third shift work depending on campaign needs.
- Environment: Candidates must be comfortable working in a fast-paced, highly regulated setting with physical activities associated with pilot plant operations.
