Quality Assurance Control

James K. Lake

** ****** ****** *******, *** York 13815

607-***-**** *********@*****.***

Objective

To obtain a chemist/manager level position or chemistry related position that utilizes my organic chemistry, analytical chemistry, project

management, process improvement/development, chemical engineering, safety and QA/QC experience.

Professional Summary

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Organic chemist with 20+ years experience in the pharmaceutical industry developing and executing chemical syntheses, process

development improvements, troubleshooting, and radio syntheses. Expertise handling hazardous waste and managing environmental

issues and regulations. Demonstrated ability to solve chemical related problems and oversee new challenges including performing proof

of concept investigation for new compounds, developing and improving chemical processes, and implementing commercial launch

operations. Proven ability to manage multiple projects simultaneously, resolve problems, and develop solutions within aggressive

timelines. Complied with cGMPs, SOPs, DOT regulations and OSHA regulations and worked with cross functional teams of engineers,

chemists, technicians, purchasing employees, and quality assurance personnel. Expertise in organic chemistry, analytical chemistry,

chemical engineering, project management, quality control, manufacturing, supervision, health and safety, hazardous materials handling

and emergency response, and environmental chemistry. Skilled in writing reports and conducting presentations at meetings and industry

conferences.

Experience

DMV International, Delhi, New York, Temporary Position Through Manpower 11/2009 – 02/2010

Process Chemist

Conducted Protein hydrolysis laboratory experiments and analysis of results.

Reviewed batch records and compiled databases.

Gained experience in a variety of filtration techniques, evaporation and drying operations, HTST pasteurization. Developed a

solid understanding of proteins and protein hydrolysis.

Norwich Pharmaceuticals, Inc., Norwich, New York, 02/2009 – 05/2009

A pharmaceutical manufacturing company that markets drugs for pharmaceutical companies including combining excipients with active

ingredients and packaging.

Chemist III

Worked in Quality Control as a level III chemist on a management track before business needs prompted an early release.

Oversaw daily quality control analytical testing of finished product, safeguarded hazardous and radioactive materials at contract

manufacturing facility, and supervised production, product packaging, and product launches.

Performed chemical analysis using a variety of analytical techniques including HPLC, Near IR, Ft-IR, Karl Fischer and UV and

presented recommendations to revise methodologies and techniques to improve safety and increase efficiencies.

Reviewed notebooks and documented all work in accordance with federal DOT and OSHA regulations, SOPs, and GMPs;

developed a sound understanding of GMPs, GLPs, and quality assurance issues and expanded knowledge of analytical chemistry.

Procter and Gamble Pharmaceuticals, Norwich, New York, 1992 – 2009

A world renowned leader in consumer products including Crest toothpaste, Jiff peanut butter, and Tide laundry detergent as well as

pharmaceuticals such as Dantrium, Asacol, and Actonel.

Principal Researcher (2001 – 02/2009)

Conducted organic chemical syntheses, chemical process scale-up, and engineering design and troubleshooting, serving as

principal research chemist, radio chemist, chemical process engineer, and hazmat team member.

Supervised employees, managed multiple projects simultaneously with project durations up to several years, and led 3-5

member teams to work toward a common goal; trained and monitored PHD chemists, chemical engineers, and technicians.

Managed synthesis, development, design, and troubleshooting of new and marketed drugs; provided technical support for

marketed drug products and served as on-site chemistry resource by coordinating efforts to resolve issues.

Administered production operations during transfer of drug manufacturing to contract manufacturers; implemented new

equipment and process improvements and trained manufacturers.

Developed and improved chemical processes through pilot scale and commercial launch operations; consistently met project

goals within specified timeframes. Experienced in project management and operations management.

Led bulk drug synthesis for chemical development by developing a process improvement for troubleshooting an existing

process, completing laboratory testing, overseeing the scale up to large scale, and working with pilot plant team, analytical chemists,

and engineers to formulate a plan; supervised the process, communicated results to management, assessed input, and wrote reports.

Handled hazardous and radioactive materials and complied with cGMPs, SOPs, DOT regulations and OSHA regulations;

authored SOPs to comply with regulatory agencies and company policies and presented interim reports, project presentations, safety

reviews, and project justifications to management.

Directed radio chemistry synthesis including tritium and carbon 14 labeling, shipped radio chemicals and documented

radiochemical data required by federal agencies, and oversaw chemical engineering process scale up.

Studied chemical production process to improve chemical processing by gaining a better understanding of the impurity profile

to adapt to changing FDA guidelines; researched literature, analyzed reaction conditions, and presented research rationale and logic

with fact-based arguments to gain support from chemists, engineers, and production workers; secured agreement of optimal process

conditions by explaining mechanisms, identified formerly uncharacterized impurities, and authored technical reports.

James K. Lake Page 2

Procter and Gamble Pharmaceuticals, cont’d

Selected Accomplishments

Saved hundreds of thousands of dollars during API development by identifying a less costly production alternative, testing the

chemistry by performing synthetic development, coordinating and responding to complex synthetic requests, and presenting

alternative to management; process was implemented in world-wide production and is still being used today.

Prevented $1 million in API losses from potentially contaminated key intermediate after routine maintenance uncovered a glass

fracture in one of the production facility reactors by proving batches were glass-free; researched reactor manufacturing history,

consulted with vendor experts to determine the cause and timing of the incident, and gathered facts by designing experiments with

engineers and analytical chemists to ascertain the extent of the loss.

Improved transfer process by developing fixes that reduced isolation and drying inefficiencies and eliminated impurities;

solutions were implemented within an aggressive timeline to allow stopped process validation work to resume.

Collaborated on a cross-functional team to develop a method to purify 60 metric tons of a contaminated key intermediate and

maintain production timing by designing a lab purification process, using kilo lab scale for testing, and supervising production

including coordinating interdepartmental efforts and providing regular updates; conducted production scale work in pilot plant and

produced sufficient purified material to supply commercial needs for a year.

Eliminated a time consuming supplemental hydration step by modifying synthesis to shorten product filtration time and produce

a highly stable hydrate less prone to impurity.

Associate Scientist (1992 – 2001)

Managed projects and participated in planning, design, and construction of radio synthesis facility.

Trained new chemists and technicians and participated on site and county hazmat teams.

Conducted numerous radioactive and stable labeling reactions to meet necessary testing requirements of new drugs including

Actonel, Azimilide, and Didronel; wrote technical reports and laboratory documentation.

Selected Accomplishment

Saved hundreds of thousands of dollars by coordinating complex synthetic problem efforts and responses.

Professional Memberships

American Chemical Society, 2005 – 2009

International Isotope Society (IIS), 1992 – 2004

Skills

Microsoft Word, Excel, Access, Project, Oracle, Power Point, Chem Draw, STN Express, Chemical Reaction Databases

HPLC, MS, Ft-IR, NMR, TLC, UV Spectroscopy, GC, Liquid Scintillation Counter, LabMax, Karl Fischer, Mass Spectrometry

Automated Reactors, RC-1 Reactors, Lasentec Reactor

Education

Empire State College, Saratoga Springs, New York

Master of Business Administration, in progress

Coursework in Project Management, Accounting & Finance, Operations Management, High Performance Management, Managerial

Economics, Managerial Decision Making, Marketing, Executive Assessment & Development

Empire State College, Saratoga Springs, New York

Bachelor of Science in Chemistry

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