Nigel Lewis
Summary
Detail-oriented Analytical Chemist with expertise in pharmaceutical method development/validation. Highly adaptive, displaying proficiency in a wide range of skills including chemical analysis, technical writing, data management, and coding. Exemplary history of organization and efficiency in industrial laboratory settings. Experienced working in cGMP environments with a focus in 5S/Lean Management systems.
Overview
7
7
years of professional experience
Work History
Analytical Chemist (Research & Development)
Pharmaceutics International, Inc
07.2022 - Current
- Executed development and validation of analytical test methods for novel and commercial drug products.
- Performed analysis using a variety of methodologies including HPLC, Particle Size Determination, UV-Spectrometry, Assay/Impurity, Dissolution, etc.
- Documented analysis results according to cGMP/GLP standards.
- Performed daily maintenance and calibration of laboratory instrumentation.
- Authored technical documents including validation protocols, test methods, and instrument SOPs.
Analytical Chemist
Curio Manufacturing
03.2021 - 07.2022
- Performed analysis of medical cannabis intermediary and finished products using HPLC and GC instrumentation to generate detailed purity reports for use in production/formulation.
- Calibrated and maintained laboratory spectrometers and chromatographs.
- Developed laboratory testing programs and data analysis while adhering to SOPs, ECOs, batch records and work instructions.
- Served as backup for IT staff members, diagnosing and solving system maintenance emergencies.
- Increased lab efficiency through the implementation of quality control procedures and maintenance and improvement of data management systems.
Extraction Technician III
Curio Manufacturing
02.2020 - 03.2021
- Worked as the 2nd shift Senior Extraction Technician leading a small team to help medical cannabis-processing operations to substantially increase output for increasing manufacturing needs.
- Performed operation and maintenance of high-output extraction and distillation equipment.
- Implemented cGMP compliant maintenance of laboratory records and documentation.
- Drafted and reviewed SOPs for newly acquired laboratory equipment.
Laboratory Consultant
Ellis Industries
05.2019 - 11.2019
- Drafting proprietary operational, safety, and diversion-prevention procedures for facility in accordance with current good manufacturing practice standards (cGMP)
- Drafted equipment list that was both within company budget and would yield best return on investment
- Designed laboratory layout including placement of equipment and security checkpoints
- Co-authored Licensing Application which placed 31st out of 200+ applicants (final results under review)
Laboratory Operations Manager
DCXtracts
06.2017 - 05.2019
- Developed standard operating procedures and document work-flows for current and future process steps
- Exhibited proficiency in operation and maintenance of complex plant material extraction equipment
- Consistent industry standard extraction efficiency of 75-85% target plant component verified by independent testing facility.
- Maintained detailed electronic and written logs containing applied methods, observations and production metrics for each extraction process
- Offered data-driven recommendations aligned with overall company strategies and prioritized process improvement initiatives
- Investigated and resolved customer complaints through pre-process consultation and post-extraction analysis
Education
Bachelor of Science - Biochemistry & Molecular Biology
Pennsylvania State University
University Park, PA06.2016
Skills
- HPLC /GC Analysis
- Process Improvement
- LIMS Maintenance
- Data Analysis
- Excel Automation/Coding
- Laboratory Operations
- Technical Writing
- Unique Problem Solving
Hobbies
- Multi-instrumentalist with a focus in electric bass performance techniques
- 10+ years recording/performing experience
- Multimedia visual art
- Amateur photography enthusiast
Timeline
Analytical Chemist (Research & Development)
Pharmaceutics International, Inc
07.2022 - Current
Analytical Chemist
Curio Manufacturing
03.2021 - 07.2022
Extraction Technician III
Curio Manufacturing
02.2020 - 03.2021
Laboratory Consultant
Ellis Industries
05.2019 - 11.2019
Laboratory Operations Manager
DCXtracts
06.2017 - 05.2019
Bachelor of Science - Biochemistry & Molecular Biology
Pennsylvania State University
Similar Profiles
Audrey SiesAudrey Sies
Manufacturing Quality Assurance Associate at Pharmaceutics International Inc. (Pii)Manufacturing Quality Assurance Associate at Pharmaceutics International Inc. (Pii)
Mark GundersenMark Gundersen
Program Manager at Pharmaceutics International, Inc.Program Manager at Pharmaceutics International, Inc.
Luke FontaineLuke Fontaine
Territory Manager at Pinnacle PharmaceuticsTerritory Manager at Pinnacle Pharmaceutics