Assoc. Dir – Bacterial Fermentation SME
| Company | Inventing for Life |
|---|---|
| Location | North Wales, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- Bachelor of Science (BS) degree with eight (8) years working experience in bacterial fermentation or a related discipline in a pharmaceutical, biotech, or academic setting; OR
- Master of Science (MS) degree with six (6) years working experience in bacterial fermentation or a related discipline in a pharmaceutical, biotech, or academic setting; OR
- PhD with concentration in Biology, Microbiology or related science with three (3) years working experience in bacterial fermentation or a related discipline in a pharmaceutical, biotech, or academic setting.
- Experimental Design
- Ability to collect and analyze data
- Expertise in a range of molecular and cellular characterization techniques
- Solid computer skills, independent experimental design and execution, and analytical problem-solving capabilities.
- Good verbal and written communication skills.
- Demonstrated initiative and innovative process-oriented thinking within a team environment.
- Ability to lead and coach others to solve problems.
- Strong problem-solving skills and a hands-on approach to problem solving
- Project management skills and experience
- Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.
Responsibilities
- Provide microbiology / bacterial fermentation subject matter expertise support to the production departments that manufacture capsular polysaccharide-based vaccines.
- Project lead for the optimization of capsular polysaccharide production in bacterial fermentation cultures.
- Designs and leads execution of experimental protocols using lab facilities and/or production equipment at full scale to enhance bacterial fermentation process understanding.
- Communicating study designs and data driven results to all levels within and across organizations and incorporating stakeholder feedback.
- Provide microbiology support to operational investigations and problem-solving, including leading investigations and analyses to determine root cause and impact, recommending corrective actions, and seeing them through to successful, sustainable implementation.
- Providing microbiological leadership and support for a vaccine manufacturing facility, including data analysis, troubleshooting, problem solving, coaching/teaching, preparing, reviewing and approving relevant documentation for technical and regulatory compliance.
- Hands-on leadership and participation in laboratory activities / production floor.
- Examines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
- Authors and approves technical documentation to support manufacturing investigations and process enhancements.
- Collaborates and engages with counterparts within technical operations, site manufacturing, commercialization, our Research Division, and process support labs within our global network.
- Troubleshooting of suspected Microbiological Contamination incidents.
Preferred Qualifications
- Experience in vaccine development or manufacturing
- Track record of publications
- Experience with natural product discovery and production
- Experience with bacterial fermentation optimization
- Experience with cultures which generate capsular polysaccharides
- Working in a cGMP environment
- Sterile, aseptic, or microbiological experience in a manufacturing environment
- Working knowledge of regulatory expectations of pure culture processing