Milton Birch
Zebulon,NC
Summary
Experienced Chemist with vast working knowledge in the Pharmaceutical industries. Strong professional skilled in Quality Control, Analytical Development, Method Validation, Technical Writing (SOPs, Validation Protocols and Development Reports, etc.) and Project Management, Leadership ability. Strong analytical aptitude, scientific judgment, and ability to multi-task in a fast passed environment adhering to cGMP rules. Strong Investigation process, in determining root cause, utilizing the Method one Investigation analysis tools (6M Methodology: Man, Method, Machine, Mother Nature, Measurement and Material; and the DIMAC (Define, Measure, Analyze, Improve, and Control) method process. Strong ability to work in a team setting meeting company's goals and objectives. Analytical Instrumentation experience: High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Dissolution testing, Infrared (IR), Atomic Absorption (AA), Inductively Coupled Plasma-Optical Emission Spectroscopy (ICPOES), Laser Diffraction Particle Size and Ultra Violet (UV). Proficient in Empower, Total Chrome, Cheromeleon, Microsoft Office (Excel, Word, PowerPoint, etc.) and other LIMS systems and global Quality Tracking System (gQTS), Electronic Quality management System (eQMS) and Sherlock.
Overview
21
21
years of professional experience
Work History
Quality Engineer - Investigation
Pfizer, Inc.
10.2019 - Current
- Performs Manufacturing and Production Investigations for batch release
- Investigations are conducted per the investigational analysis tools (6M Methodology: Man, Method, Machine, Mother Nature, Measurement and Material; and the DMAIC process: Define, Measure, Analyze, Improve, and Control) to determine root cause and solution(s)
- Per the deviation root cause, a Corrective Action Preventative Action (CAPA) is initiated
- Completed investigation's report is reviewed by Area Manager, Site Quality Assurance and any additional approval depending on the deviation
- Approved investigation draft/report is uploaded to the electronic Quality Management System
- Peer reviewed other colleague drafts reports
- Performs periodic training, in the Pfizer Learning Solution portal.
Senior Chemical Quality Specialist
Pfizer, Inc.
11.2017 - 09.2019
- Performed testing (Wet Chemistry, Moisture, pH and ID) on Pharmaceutical Products
- Performed additional analysis for Assay and Impurities on Pharmaceutical products using High Performance Liquid Chromatography (HPLC) or Gas Chromatography (GC) where required
- Data and results from analyses are calculated and processed using the Empower software
- All processed results are entered into the Laboratory Information Management System (LIMS)
- Trained periodically on Standard Operating Procedures and Test Methods
- Performed testing for Investigational purposes related to Laboratory Investigation Report.
Analytical Development Chemist
Lannett Pharmaceutical, Inc. (Formerly, Kremer's Urban Pharmaceuticals, Inc.)
08.2013 - 11.2017
- Drafted Development Reports after a successful development work leading to validation
- Development report and data are compiled and analyzed; a validation protocol is subsequently drafted from the data generated during development testing
- Validation protocol is then executed using the validation parameters (Linearity, Specificity, Repeatability, Stability, Robustness, Precision, etc.), via GC/HPLC or HPLC
- After the successful completion of validation process, draft validation report and submit for review to Colleague, Supervisor, Manager and Quality Assurance
- Change control is then implemented, and a new analytical method is put in place
- Performed testing and verification for Complete Response or Information Request from FDA
- Support the transfer of methods from Analytical Development to Quality Control Laboratory
- Data are calculated and processed using Chromeleon software
- Peer reviewed reports and protocols of colleagues.
QC Chemist II
Cadista Pharmaceuticals, Inc.
03.2011 - 07.2013
- Performed Quality Control testing on pharmaceutical products, Wet Chemistry, Assay, CU, Impurities, Dissolution, Moisture, and IDs
- Further analyses for Assay, Impurities, Dissolution and CU are carried out using HPLC, or GC
- Performed Method Validations, Cleaning Validation and Method Transfers
- Calibrate Instruments, HPLC, GC, IR, KF, UV-vis and perform preventative maintenance
- Train and coordinate work schedules for Chemist I and Lab Technician
- Performed data analysis and data calculation using Empower and drafter report.
QC Chemist II
TEVA Pharmaceuticals
04.2007 - 01.2011
- Performed testing (Assay, Impurities, IDs, Wet Chemistry and Dissolution) on Finished Products, Stability Samples, and Raw Materials
- Additional analyses: Assay, Impurities and Dissolution, performed using UV-vis, HPLC, or GC
- Performed Method Verification and Method Transferred
- Carried out Laboratory Investigations and write up reports
- Processed data and wrote reports using Total Chrome and SQL LIMS systems.
Chemist, ANALYTICAL DEVELOPMENT/ R&D
Bristol-Myers Squibb
01.2005 - 04.2006
- Drafted and wrote Development Reports and Validation Protocols after successfully completing development testing and analyses of pharmaceutical products by High Performance Liquid Chromatography (HPLC) or Gas Chromatography (GC)
- Validation processes/parameters are executed in the laboratory per protocol approval
- Processed data from analysis using Empower software program
- Edited data, drafted protocols, and reports of projects (Development / Validation)
- Calibrated and performed preventative maintenance periodically.
- Enhanced product quality by developing and optimizing chemical processes and procedures.
QC Chemist, CHEMISTRY Lab
Bristol-Myers Squibb Medical Imaging
06.2003 - 12.2004
- Quality Control testing, ID, and Wet Chemistry on Raw Materials and Finished Products
- Performed routine Calibrations on Laboratory instruments
- Analysis on Finished Products, and Raw Materials via HPLC, UV-vis, AA, GC or FTIR
- Data are reviewed, edited, and processed using Atlas and LIMS.
Education
Master of Business Administration -
Syracuse University
Syracuse, NY05.2018
B.Sc. Degree, Chemistry -
University of Liberia
Monrovia, Liberia01.1988
Skills
- Problem Solving, Team Player, Microsoft Word, Technical Writing, Project Management, Strong Work Ethic, Analytical and Quantitative
Affiliations
- American Chemical Society
- Association of Analytical Chemist
Timeline
Quality Engineer - Investigation
Pfizer, Inc.
10.2019 - Current
Senior Chemical Quality Specialist
Pfizer, Inc.
11.2017 - 09.2019
Analytical Development Chemist
Lannett Pharmaceutical, Inc. (Formerly, Kremer's Urban Pharmaceuticals, Inc.)
08.2013 - 11.2017
QC Chemist II
Cadista Pharmaceuticals, Inc.
03.2011 - 07.2013
QC Chemist II
TEVA Pharmaceuticals
04.2007 - 01.2011
Chemist, ANALYTICAL DEVELOPMENT/ R&D
Bristol-Myers Squibb
01.2005 - 04.2006
QC Chemist, CHEMISTRY Lab
Bristol-Myers Squibb Medical Imaging
06.2003 - 12.2004
Master of Business Administration -
Syracuse University
B.Sc. Degree, Chemistry -
University of Liberia
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