Dalton Lentz

Supervisor, Drug Substance Development & Manufacturing @Cambrex

Longmont, CO, US

I function as a Supervisor and the sole Process Engineer on the Drug Substance Development & Manufacturing team, leading chemists and operators to support pilot scale (phase 1 and IND enabling) API manufacturing. I ensure process are fit-for-purpose prior to scaling, including process feasibility and safety assessments of operations, and that the chemical reactions to be conducted scale correctly from the lab to the plant. I create and review cGMP manufacturing batch records and quality documentation (change control, deviations, CAPAs) to support drug substance manufacturing. I specify, procure, and qualify equipment purchased through management of department CAPEX budget.Responsibilities include:• Supervisory responsibility including performance management and career development of direct reports. Direct others in task delegation in matrixed responsibilities.• Lead and be a primary contributor in the manufacturing technical transfer process, including process safety evaluation, process feasibility, identifying equipment needs, equipment cleaning requirements and strategies, and implementation of the identified considerations.• Contribute to department management of the GMP and non-GMP documentation processes including batch records and other quality documents used in the quality management system (change control, deviation, CAPA, etc.).• Work with senior department management to contribute to departmental direction, policy, strategy, proposal writing, production schedule, equipment onboarding and qualification and departmental training.• Maintain project timelines and tracking deliverables (both internal and external) to maintain production schedules.• Perform drug substance operations in execution of a manufacturing batch record under GMP or non-GMP conditions as needed.• Execute Operational Excellence initiatives.• Support problem solving of technical issues pertaining to drug substance manufacturing.

Rose-Hulman Institute of Technology

Master of Science (M.S.), Engineering Management

Rose-Hulman Institute of Technology

Bachelor of Science (BS), Chemical Engineering