Fermentation Manager

JOB SUMMARY:

We are seeking a Fermentation Manager who will lead the fermentation production activities for reagent grade and GMP manufacturing of bacterial products including live biotherapeutic products, bacterial toxins, lipopolysaccharides, and other bacterial produced proteins.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Successfully lead the development, scale-up and fermentation production of bacterial products, both for reagent grade and cGMP manufacturing products Improve technical capabilities and quality practices within the department Supervise, mentor and provide necessary training for development of fermentation staff
• Lead the execution, completion and review of manufacturing documentation including batch production records, quality system documents and reports 
• Serves as subject matter expert in multidisciplinary project teams and/or sub-team meetings within the company or with clients
• Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved economics and process robustness Support deviation investigations and identifying CAPAs to resolve manufacturing related issues Broad use of expertise and knowledge to solve complex non-routine technical problems Lead improvements in process and methods Coordinate and facilitate communication across multi-disciplinary groups Ensure compliance with all environmental, health, safety, and cGMP regulations Position requires work with Select Agents and Toxins in which access is covered under Federal policies
• Contributes to building a culture that encourages continuous learning, improvement, and innovation, and encourages and mentors team members to expand their technical skill base

QUALIFICATION AND EXPERIENCE:

• BS/MS/PhD in biology, microbiology, biochemical or biomedical engineering, or related biological field
• BS 10+ years of Biotechnology, Bioprocessing or Pharmaceutical industry experience with a minimum of 5 years of managerial experience
• MS 7+ years of Biotechnology, Bioprocessing or Pharmaceutical industry experience with a minimum of 3 years of managerial experience
• PhD 2+ years of Biotechnology, Bioprocessing or Pharmaceutical industry experience with a minimum of 2 years of managerial experience
• 3+ years of cGMP manufacturing experience

KNOWLEDGE, SKILLS AND ABILITIES:

• Fermentation experience with a variety of bacterial organisms including aerobic and anaerobic microorganisms
• Experience with upstream harvest processes including tangential flow filtration, depth filtration and centrifugation
• Experience with single-use bioreactors a plus
• Highly independent and self-motivated and integrates well within a team
• Strong ability to troubleshoot technical problems
• Good organizational skills with ability to meet deadlines and prioritize work on multiple projects
• Excellent oral and written communication skills
• Dedicated, hard-working and dependable
• Must be able to acquire security background clearance from FBI and CDC