Sr. Spclst, Bacterial Fermentation SME

Job Description

The Polysaccharide Vaccine Technical Operations organization within our Company Divisions is responsible for supporting vaccine operations as the technical subject matter experts. Responsibilities of the organization include technical process support, project management/change control, deviation management, and continuous improvement.

The Associate Director role will be to provide in-house subject matter expertise for bacterial fermentation. The subject matter expert will be responsible for optimization of capsular polysaccharide productivity during culture biosynthesis, investigation support for atypical processing events during fermentation, and further characterization of the culture and purified capsular polysaccharides. The ideal candidate will have a strong background in microbiology and bacterial fermentation with natural product discovery experience a plus.

Responsibilities Include but are not limited to:

• 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

Minimum Education Required and Experience:

• Bachelor of Science (BS) degree with five (5) years working experience in bacterial fermentation or a related discipline in a pharmaceutical, biotech, or academic setting; OR

• Master of Science (MS) degree with four (4) 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 experience in bacterial fermentation or a related discipline in a pharmaceutical, biotech, or academic setting.

Required Skills and Experience:

• 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.

Preferred Skills and Experience:

• 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