Quality Chemical

Milt Williams

*** ********* ******* *****

Godfrey, Illinois 62035

618-***-****

e-mail: ****.************@*****.***

OBJECTIVE: Obtain a position where my pharmaceutical/chemical manufacturing experience, quality control/R&D experience, and analytical skills could be utilized.

EXPERIENCE:

Lee Biosolutions, Inc. Maryland Heights, Missouri

Senior Analytical Chemist June 2018 to August 2020

Identify and justify purchase of analytical equipment and lead equipment qualification and validation studies.

Develop and optimize HPLC analytical methods for excipients and proteins.

Author, revise, and review analytical standard operating procedures, assay procedures, specifications, certificates of analysis and other documents.

Design and execute analytical method validation studies and product stability studies.

Provide analytical support for R&D and manufacturing projects.

Manage complex analytical projects (internal or for outside customers). Communicate with the customer, external laboratories, and internal departments. Track deliverables, timeline and budget.

Train and mentor junior employees.

Lead investigation of complaints and non-conformances.

Perform additional duties to support efficient functioning of the analytical laboratory (calibration and performance maintenance, maintaining inventory of reagents, etc.)

Perform standard batch release for the QC department.

Act as a technical resource who supports the need for adopting new technologies with the ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

Ability to deal with complex problems in novel situations with creative and innovative solutions.

Ability to read and comprehend complex instructions. Ability to effectively communicate complex ideas, data, and conclusions to coworkers, customers, outside laboratories and auditors. Strong written and verbal communication skills.

Ability to perform complex mathematical, statistical, and trend analysis of data.

Ability to use Microsoft® Office, Excel, Word, and Outlook. Ability to graph or track data produced during a typical manufacturing procedure. Ability to prepare presentations with PowerPoint® or pdf templates.

Typical equipment used: HPLC with diode array and refractive index detection using local Chemstation® and Chemstation CDS® chromatography software, FTIR, Dimension Clinical Chemistry System, Immulite Immunoassay System, Gel electrophoresis and blotting equipment, Osmometer, Stago Hemostasis Analyzer, UV-VIS spectrophotometers, Multi-well plate reader, Karl Fischer Titrator, Laminar flow hood, shakers, Eppendorf™ fixed-volume and adjustable pipettes, pH and conductivity meters, and centrifuges.

Ability to perform all regulated activities under USP and/or EP requirements according to GLP, GDP, cGMP, ICH, FDA and EU guidelines.

American Radiolabeled Chemicals, Inc. St. Louis, Missouri

Senior Analytical Chemist November 2017 to December 2017

Performed analytical HPLC, preparative HPLC, LCMS and final product purification involving carbon-14 and tritium radiolabeled compounds.

Performed final product packaging involving carbon-14 and tritium concentration changes as well as solvent changes to meet individual customer requirements.

Responsible for the installation, calibration, troubleshooting and maintenance of HPLC instrumentation as well as organizing and maintaining chemical and product inventory.

Alkem Laboratories Fenton, Missouri

Analytical Chemist (Contract) November 2016 to April 2017

Performed USP/EP compendial testing involving ointments, creams, liquids, nasal sprays, and oral solid dosage formulations in both immediate and extended release applications. Typical analysis/instrumentation includes content uniformity, homogeneity, viscosity, osmolality, FT-IR, Karl Fischer % water determination, UV-VIS Spectrophotometer, HPLC, TOC and GC with FID and Headspace capabilities for assays, residual solvents and impurities/related compounds using Chromeleon software.

Participated in method development & validation activities, product quality investigations and authoring CAPAs to support product testing as well as troubleshooting analytical methods, instrumentation and Chromeleon software.

MilliporeSigma, Merck KGaA St. Louis, Missouri

Quality Control Scientist (Contract) August 2016 to November 2016

Performed USP/EP compendial testing of raw materials, in-process samples and finished pharmaceutical products and stability samples.

Utilized internal written procedures to perform routine product testing.

Performed work in accordance with current GMPs and demonstrated proper laboratory safety and housekeeping practices.

Contributed to the support function of the lab.

Virbac Animal Health, Inc. Bridgeton, Missouri

Quality Control Analyst April 2011 to July 2016

Performed full USP/EP compendial testing of raw materials, in-process samples and finished pharmaceutical products for the companion animal healthcare market.

A brief list of routine monograph testing/instrumentation would include: ph, viscosity, disintegration, dissolution, melting point, loss on drying, residue on ignition, Karl Fischer % water determination, molecular weight titrations, UV-VIS Spectrophotometer, assay/impurities/related compounds and residual solvents (USP <467>). HPLC, and GC with FID and Headspace capabilities.

Completed multiple classes regarding cGMP training involving FDA Regulated Products in 21 CFR 210/211, Biological Products: General in 21 CFR 600/610, Quality Systems Regulations in 21 CFR 820 and their application to USP, ICH and EU guidelines.

Familiar with reviewing and executing cleaning validation protocols involving water and swab sample collection and analysis by TOC.

Experience ordering/maintaining inventories for analytical standards & chemical reagents, performing instrument calibrations, data review/audit, OOS investigations and authoring CAPAs to support product quality investigations.

Mallinckrodt Medical Inc. (Covidien) Hazelwood, Missouri

Senior Research Chemist April 2003 to July 2009

Conducted research, analysis and experimentation in the areas of nuclear medicine and x-ray contrast media.

Devised new equipment and developed formulas, processes and methods for solution of technical problems.

Designed experiments and produced results confirming the in-house need for an Inductively Coupled Plasma Atomic Emission Spectrophotometer (ICP-AES) and a voltammetry instrument.

Analyzed organic and inorganic compounds to determine chemical and physical properties.

Familiar with authoring and adhering to cGMPs that involved laboratory functions.

Utilized techniques such as chromatography, spectroscopy and spectrophotometry.

Trained and supervised six research chemists in ICP-AES and voltammetry which produced significant improvements in precision, accuracy and productivity.

Developed and validated many high performance liquid chromatography (HPLC) analytical methods utilizing ultra-violet and refractive index detection.

Developed and validated multiple ICP-AES analytical methods.

Developed and validated multiple voltammetry analytical methods.

Trained numerous analytical research chemists, senior research chemists and principal research scientists in regard to HPLC.

Provided training, guidance and supervision for analytical method transfers (both internally and externally to contract labs) in regard to the methods I developed and validated (HPLC, GC, ICP and Voltammetry).

Conducted research into composition, structure, properties, relationships and reactions of various substances.

Completed multiple classes regarding cGMP training involving FDA Regulated Products in 21 CFR 210/211, Biological Products: General in 21 CFR 600/610, Quality Systems Regulations in 21 CFR 820 and their application to USP, ICH and EU guidelines.

Successfully lead an eight person team by developing and validating three HPLC analytical methods which provided the solution to generating weight/weight percent results for the active pharmaceutical ingredient (API) and nine related impurities for an x-ray contrast agent.

Provided technical leadership, mentoring, and supervision as needed.

Successfully developed and validated all of the non-published HPLC and voltammetry analytical methods for technetium sestamibi, a generic version of Cardiolite, which is the gold standard of myocardial perfusion imaging agents used in nuclear medicine to evaluate coronary blood flow.

Authored qualification reports, validation reports, analytical test methods, standard operating procedures and justification of specifications for multiple projects.

Authored analytical method summaries and justification of specifications for the chemistry, manufacturing and controls section of an abbreviated new drug application submission to the FDA for multiple projects.

Familiar with Microsoft Word, Excel, PowerPoint, SharePoint, Project and Access.

Routinely used Agilent Chemstation, Agilent OpenLab and TotalChrom data collection software for instrumental analyses and calibrations.

Experience using laboratory information management system (LIMS) software to generate and maintain stability profiles.

Familiar with Metric Stream, Minitab software, data review/audit, authoring CAPAs in regard to product quality investigations/deviations, change control and electronic document management system (EDMS).

Completed four weeks of six sigma black belt training.

Familiar with ISO class 6 clean room operation and monitoring.

Familiar using statistical process control to monitor/improve processes and justify adjusting specifications due to in-process manufacturing changes.

Familiar using Metric Stream software to investigate, report, organize and trend out of specification results and generate corrective action and preventative action plans.

Prepared standards and specifications for processes, facilities, products and tests.

Developed solutions to problems of unusual complexity that required a high degree of ingenuity, creativity and innovativeness.

Often acted independently to determine methods and procedures on new or special assignments.

Familiar with providing supervisory oversight to support staff.

Regularly contributed to the development of new concepts, techniques and standards.

On occasion, have made recommendations to management as to ways of improving existing operational practices/technologies etc.

Developed new applications based on professional principles and theories.

Familiar with performing work without appreciable direction and generating crucial results from self-initiated assignments.

Familiar with Non-Conformance and CAPA Management using Metric Stream software.

Experience working with different groups of people in completing assignments and projects and in achieving goals based on their abilities and strengths as well as my own in FDA regulated environments.

KV Pharmaceutical Company St. Louis, Missouri

Quality Control Analyst September 1997 to April 2003

Tested raw materials, final products and products on stability in regard to pharmaceuticals using USP/compendial analytical procedures in an FDA regulated environment.

Trained numerous analysts in regard to high performance liquid chromatography (HPLC), gas chromatography, dissolution testing and instrument calibrations.

Calibrated and performed preventative maintenance on HPLC, spectrophotometry and dissolution instrumentation.

Optimized, refined and revalidated HPLC methods from the Research and Development department and USP as needed.

Experience authoring OOS/non-conformance reports, document change control and CAPAs involving product quality investigations using TrackWise®.

Completed multiple classes regarding cGMP training involving FDA Regulated Products in 21 CFR 210/211, Biological Products: General in 21 CFR 600/610, Quality Systems Regulations in 21 CFR 820 and their application to USP, ICH and EU guidelines.

Calgon Vestal Laboratories (Steris Corporation) St. Louis, Missouri

Quality Control Analyst November 1991 to September 1997

Tested raw materials, in-process samples and final products in regard to phenolic germicidal detergents and disinfectants, quaternary germicidal detergents and disinfectants, antimicrobial/medicated lotion soaps and skin cleansers, liquid and foam hand cleansers, enzyme-based presoak cleaning solutions for medical appliances and instruments, waterless antiseptic hand rub cleansers and clean in place products for industrial applications in an ISO-9000 registered, FDA compliant, high speed liquid filling facility.

Familiar with authoring, reviewing and executing cleaning validation protocols involving water and swab samples plus various grades of stainless steel coupons and analysis by TOC and FTIR during the development of CIP 100 & CIP 200.

Provided primary support for sample analysis and personnel training in regard to HPLC, gas chromatography (GC), instrument calibrations and data review.

Calibrated and performed preventative maintenance on HPLC and GC instrumentation.

Familiar with authoring and adhering to cGMPs that involved laboratory functions.

Routinely provided manufacturing solutions via troubleshooting formulations and issuing batch adjustments/corrections based on the product formula, the analysis specifications and the product chemistry through theoretical and/or experimental means and reviewing and signing off/releasing batch records for approved product batches.

Authored validation reports, analytical methods and standard operating procedures.

Familiar using statistical process control software to monitor/improve manufacturing and packaging processes and justify adjusting final product specifications due to in-process manufacturing changes.

Provided technical leadership and mentoring as needed.

Familiar with Gamma Irradiation and Ethylene Oxide sterilization techniques used in aseptic processing.

Completed multiple classes regarding cGMP training involving FDA Regulated Products in 21 CFR 210/211, Biological Products: General in 21 CFR 600/610, Quality Systems Regulations in 21 CFR 820 and their application to USP, ICH and EU guidelines.

Sigma Chemical Company St. Louis, Missouri

Chemical Operator February 1989 to November 1991

Experience in large scale plant processing of biological buffers in a bulk organic synthesis plant; this ranges from ordering the raw materials to scheduling the reactor, centrifuge, dryer and monitoring/analyzing intermediates (through HPLC, GC or titration) to determine the completeness of reactions and the weighing, packaging and analysis of the final products.

St. Louis Testing Laboratories, Inc. St. Louis, Missouri

Chemist August 1988 to February 1989

Analyzed organic and inorganic compounds to determine chemical and physical properties & composition utilizing chromatography, spectroscopy, and spectrophotometry techniques on a wide variety of sample matrices.

American Bottoms Regional Wastewater Treatment Facility Sauget, Illinois

Chemist June 1987 to August 1988

Analyzed wastewater quality utilizing instrumental and wet chemical EPA methodology and compared/reported results against EPA limits/standards.

EDUCATION: St. Louis College of Pharmacy St. Louis, Missouri

1984-1987

Lewis and Clark Community College Godfrey, Illinois

1982-1984

REFERENCES: Available upon request

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