Teams at KBI Biopharma

Lead and supervise analytical and formulation testing projects, including method development, validation, transfers, compendial verification, and stability/release testing for non‑GMP and GMP products. Manage project teams, review and produce regulatory-quality documentation, support product and formulation development, ensure cGMP and SOP compliance, and mentor junior staff while handling staffing and operational responsibilities.

Assists the site EHS&S Head in implementing environmental, health, safety, and sustainability programs. Manages hazardous waste, wastewater, emissions, resource monitoring, environmental indicators, equipment, consumables, service-provider contracts, and regulatory improvements. Participates in incident investigations, risk management, LOTO, confined-space entry, industrial hygiene, hazard communication, PPE, emergency management, and engineering-control initiatives. Coordinates with departments and operations to mitigate risks and maintain compliance.

Lead MS&T operations for tech transfer, process validation, and support labs at the Durham manufacturing site. Manage multidisciplinary engineering and scientific teams, coordinate with Process Development, Quality, Supply Chain, Facilities and Manufacturing to enable successful clinical and commercial product introductions, ensure cGMP compliance, support PAI, drive standards and process scale-up, recruit and develop talent, and represent the department in audits and cross-functional leadership meetings.