MICHAEL SHMUKLER
Greater Philadelphia
Summary
Accomplished Biomedical Engineer with a B.S./M.S. from Drexel University, bringing over 10 years of rich experience in leading pharmaceutical and biotech companies. Adept in process development, technology transfer, and manufacturing with a specialization in drug substances, drug products, and packaging. Demonstrates a deep understanding of Quality by Design (QbD) principles, project management, and quality systems. Known for driving successful product commercialization and enhancing manufacturing processes. Combines strong academic background with extensive industry experience to deliver innovative solutions in complex pharmaceutical environments.
Overview
10
10
years of professional experience
Work History
Process Development Engineer
Merck & Co., Inc.
03.2018 - Current
- Spearheaded process parameter studies for biologic drug products, enhancing PPQ execution and commercialization
- Authored process characterization documentation, facilitating technology transfers and product filing readiness
- Directed a unit operation study, awarded for innovation, reducing process development time across multiple programs
- Implemented a drug product value stream map, optimizing change control decision-making
- Led a department-wide second person review training initiative, enhancing compliance and SOP alignment.
Process Engineer
PCI Pharma Services
09.2017 - 02.2018
- Conducted engineering studies to optimize blister packaging processes, achieving Operational Qualification and PPQ
- Led Change Controls and Site Acceptance Tests, enhancing blister pack quality and reducing market risks
- Identified and implemented continuous improvement strategies to boost productivity and reduce costs.
Product Development Engineer
DePuy Synthes (Johnson & Johnson)
04.2016 - 09.2016
- Designed surgical instruments for Trauma sector, improving surgeon end-user experience
- Managed design control processes, aligning instrument designs with surgeon requirements
- Developed verification protocols for mechanical risk assessments of instrument designs.
Energy Improvement Engineer
Arkema
09.2014 - 03.2015
- Pioneered an energy savings initiative, conducting baseline analyses across 30+ sites for potential savings
- Developed guides for U.S
- Department of Energy software tools, enhancing staff capabilities in project evaluation.
Biopharmaceutical Associate
GlaxoSmithKline
09.2013 - 03.2014
- Compiled and analyzed process data for monoclonal antibody drug development
- Improved data entry processes using Lean Six Sigma methodologies, enhancing operational efficiency.
Education
B.S./M.S. Biomedical Engineering -
Drexel University
Graduate Certificate in Engineering Management -
Skills
- Quality by Design (QbD)
- Project Management
- Process Development & Technology Transfer
- Quality Systems & Compliance
- Data Analysis & Process Optimization
- SAP & Microsoft Office Suite (incl Microsoft Project)
- Effective Communication & Team Collaboration
Websites
Timeline
Process Development Engineer
Merck & Co., Inc.
03.2018 - Current
Process Engineer
PCI Pharma Services
09.2017 - 02.2018
Product Development Engineer
DePuy Synthes (Johnson & Johnson)
04.2016 - 09.2016
Energy Improvement Engineer
Arkema
09.2014 - 03.2015
Biopharmaceutical Associate
GlaxoSmithKline
09.2013 - 03.2014
B.S./M.S. Biomedical Engineering -
Drexel University
Graduate Certificate in Engineering Management -
Similar Profiles
Hadi Hazoor BakhshHadi Hazoor Bakhsh
Sterile Tech 2nd Shift at Merck & Co., Inc.Sterile Tech 2nd Shift at Merck & Co., Inc.
Lisa GiovinazzoLisa Giovinazzo
Administrative Assistant at Merck & Co., Inc.Administrative Assistant at Merck & Co., Inc.
Kyle-Scott PhillipsKyle-Scott Phillips
Quality Analyst at Merck & Co., Inc.Quality Analyst at Merck & Co., Inc.
Atiqur RahmanAtiqur Rahman
pharmaceutical operator at Merck & Co., Inc.pharmaceutical operator at Merck & Co., Inc.
SHAWN ZEMEKSHAWN ZEMEK
Construction Supervisor / Project Foreman at DBella BuildersConstruction Supervisor / Project Foreman at DBella Builders