Clayton A. Lutzow
Summary
Manufacturing professional with strong track record of optimizing production workflows and driving operational improvements. Highly reliable with focus on collaborative team efforts and achieving measurable results. Demonstrated expertise in process optimization and strategic planning, consistently flexing to meet evolving industry demands.
Experienced with implementing effective manufacturing strategies to maximize productivity and minimize downtime. Utilizes problem-solving skills and leadership to drive continuous improvement initiatives. Track record of fostering collaborative work environment and ensuring alignment with organizational goals.
Overview
10
10
years of professional experience
Work History
Director of Manufacturing
Abzena
04.2024 - Current
- Lead the operations teams and MSaT teams to manufacture Antibody Drug Conjugates, other Bioconjugates and Small Molecule Drug Linkers.
- Spearhead manufacturing campaigns ensuring adherence to Quality Standards, Yield Expectations, and Client Schedules.
- Continuous interfacing with clientele including manufacturing updates, technical meetings and new customer sales.
- Manage the largest department on site’s budget, personnel and revenue.
Head of MSaT
Abzena
04.2023 - 04.2024
- Guide team of Engineers, Chemists and Technical Experts to develop Antibody Drug Conjugate processes for both Bioconjugation and Linker Payload manufacturing.
- Generate cross departmental teams to ensure success across projects ranging from quality investigations to process development technology transfers.
- Act in place of Director of Manufacturing or Operations Managers in the event of their absence.
- Heavily interface with clientele including new customer discussion and current customer updates.
MSaT Process Engineer
Abzena
09.2020 - 04.2023
- Facilitate the transfer of linker payload and bioconjugation manufacturing technologies from process development to GMP manufacturing.
- Lead commissioning and qualification efforts for new processing suites and equipment including design and FAT/SAT/IQ/OQ/PQ activities.
- Support Antibody Drug Conjugates manufacturing processes for early phase clinical supply.
- Hands-on implementation of manufacturing process improvement using sound engineering and scientific principles.
- Responsible for the transfer of technologies, including cross-department and client collaboration to enable facility fit, development of process documentation, Change Controls, Investigations and other quality system deliverables.
Manufacturing Associate
Pharmaceutical Manufacturing Research Services
04.2015 - 09.2020
- Develop process and operations improvement through engineering skill set.
- Author and execute installation, operation, performance qualifications and validation documents on new equipment.
- Organize and conduct calibration, preventative maintenance on process critical equipment.
- Write, revise, review, and approve process documentation including SOPs, electronic batch records, deviations, root cause analysis and CAPAs.
- Scale-up manufacturing from R&D to commercial products in a cGMP facility.
- Handling sensitive materials including orphan drugs, CII narcotics and high potency compounds.
Education
Master of Science - Chemical Engineering
Drexel University
06.2017
Bachelor of Science - Chemical Engineering
Drexel University
06.2017
Skills
Operations management
Customer satisfaction
Production scheduling
Production procedures
Capacity planning
Process engineering
Production planning
Continuous improvement
Lean manufacturing
Timeline
Director of Manufacturing
Abzena
04.2024 - Current
Head of MSaT
Abzena
04.2023 - 04.2024
MSaT Process Engineer
Abzena
09.2020 - 04.2023
Manufacturing Associate
Pharmaceutical Manufacturing Research Services
04.2015 - 09.2020
Bachelor of Science - Chemical Engineering
Drexel University
Master of Science - Chemical Engineering
Drexel University
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