- Manufacturing experience involving fermentation, protein purification, and bulk lyophilization.
- Performed fermentation at all scales from shake flasks to large-scale production.
- Increased production yields through media optimization, fermentation parameter optimization, and strain improvements.
- Experienced in fermentations involving recombinant microorganisms, Bacillus sp., Streptomyces sp., and numerous other microbes producing a wide spectrum of microbial products.
- Experience in developing products involving secondary metabolites including media and parameter optimization.
- Involved in control of contamination including both microbial and phage.
- Managed sterile operations in API manufacturing involving cleanroom activity for ISO 5, 7, and 8 areas.
- Experienced in production of Monoclonal Antibodies. Led a cross-functional team to enhance bioburden control strategies within the production area.
- Led productivity improvement projects to reduce COGS and increase productivity specifically focusing on cycle time reduction.
- Supported operations both domestically and internationally (Belgium, Germany, Brazil, Ireland, England) on manufacturing challenges in microbial fermentation, vaccines, and sterile fills.
- Prepared SOPs for operations to utilize for task performance.
- Manufacturing experience involving sterile pre-filled syringes and vials.
- Involved in the formulation of API of both aqueous and oil-based excipients.
- Utilization of isolator technology as well as RABS to provide product protection.
- Involved in control of contamination by microorganisms – developed strategies to reduce risk and enhance control.
- Developed environmental monitoring programs with required risk assessments and use of approved disinfectants.
- Worked with Gamma-radiation, eBeam, and VPHP to provide sterility to both products and devices.
- Led investigations for sterility failures and loss of sterility assurance including CAPAs.
- Developed process simulation approaches for complex processes.
- Prepared Product Protection Control Strategy documents for multiple sites to support contamination issues and establish a strong culture of sterility assurance.
- Facilitated Prior Approval Inspection preparations and General Inspections with FDA at multiple sites around the world.
- Prepared documentation for FDA approval of both CBE30 and PAS as well as introductory process proposals (briefing documents).
- Prepared multiple presentations for the FDA and EU to assist in introducing project updates, plant expansions, and projects seeking regulatory guidance.
- Assisted in preparing documents in support of manufacturing issues to demonstrate compliance.
- Served on ISPE committee to develop a certification program.
- Managed QC laboratory staffs for both microbiology and chemistry functions.
- Served as a team member on multiple technical due diligence activities. Specifically focused on manufacturing capability.
- Training of personnel in bioburden control and aseptic technique (specifically disinfecting, gowning, fundamental microbiology, and process simulations (media fills)).
- Provided multiple sessions on educating staff and community on biotechnology and recombinant microbes.
- Provided and Lead initiatives at the manufacturing scale to utilize Quality Risk Management (QRM) for establishing CPPs.
- Utilized LEAN tools for process optimization for reducing cycle time.
- Have conducted multiple FMEAs in support of sterility assurance.