Quality Manufacturing
Resume:
PAGE * DAVID H. MEISER
DAVID H. MEISER
Pipersville, 267-***-****
PA 18947 www.linkedin.com/in/davidmeiser ace9ki@r.postjobfree.com
SUMMARY
Experienced Scientist with background in pharmaceutical, chemical industries; Expertise in
analytical methods development & validation, regulatory affairs external manufacturing, technology
transfers and product stability; Experience with analysis of drug substances; products. raw materials,
excipients, intermediates as well as GMP / GLP requirements; Project management, Word, Excel,
PowerPoint, Access, and laboratory data systems (electronic notebook and project tracking systems)
• HPLC • UV-Vis • Compendial techniques
• GC • Wet chemistry • FTIR
• Dissolution (Type I and • GC, HPLC and ICP-Mass • Scanning Electron
II) Spec’s Microscope
PROFESSIONAL EXPERIENCE
MERCK AND COMPANY, West Point, PA 2008-2014
Project Scientist, Global Science and Technology-Commercialization
Managed the development validation and implementation of optimized analytical methods for
physical and chemical characterization and material/product quality and stability determination.
Reviewed, conducted, and evaluated equivalency & superiority studies of analytical methods,
preformed method transfer of analytical methods, Conducted atypical, troubleshooting and out of
specification investigations. Performed routine and non-routine physical and chemical tests on raw
materials, Performed statistical data analysis. Performed unknown compound identification.
Supported product registration, changes, regulatory filings, CAPA commitments and regulatory
questions. Ensured GMP/GLP compliance of data, notebooks, memos, and reports. Created &
revised test procedures, standard operating procedures (SOP) and final reports. Trained
departmental personnel on instrumentation, SOP’s and procedures. Supervised & trained personnel.
Served as department safety officer.
• Evaluated analytical laboratory quality of external manufactures to meet quality and
productions standards reducing the Sub-Saharan Africa Raltegravir’s price to $1.85 per day.
• Reduced lab expenditures by 60% by developing and implementing a lab inventory for 1,200
different HPLC and GC columns
• Evaluated European Medicines Agency (EMA) compliance guideline for Residues of Metal
Catalysts Specification Limits and the Unites Stated Pharmacopeia (USP) monographs
<232> and <233> for elemental impurities to ensure company compliance.
• Responsible for all aspect of laboratory: Inspections, training on safety procedures, and
ensuring adherence to corporate safety SOPs and policies for every departmental personnel
• Oversaw the analytical technology transfer to of over 100 methods to 20 manufacturing and
quality facilities, internal and external to the company.
• Examined more than 15 product lines and10 vendors for potential outsourcing of the
manufacture of Merck’s active pharmaceutical ingredients, Examined and compared their
product quality to Merck’s standards to ensure quality and cost.
MERCK AND COMPANY, WEST POINT, PA 1999-2008
Scientist, Manufacturing Division-Quality, Regulatory and Analytical Sciences Dept
Performed routine and non-routine physical and chemical tests on raw materials, active
pharmaceutical ingredients, in process and finished products, and excipents. Performed testing for
support of product registrations. Performed method validations to determine surface residuals on
manufacturing equipment for cleaning validation. Conducted method equivalency testing to reduce
workload for manufacturing sites. Worked with stability and release sites in order to solve technical
problems. Assisted manufacturing sites worldwide with Out of Specification and Atypical laboratory
PAGE 2 DAVID H. MEISER
investigations including processing problems. Assisted regulatory group with responses to worldwide
regulatory agency questions and requests.
• Eliminated redundant testing of approximately 50 laboratory tests by developing vendor
qualification methodologies to accept material based upon vendor Certificate of Analysis.
• Developed, validated an alternate method for the HPLC assay of parahydroxybenzoate
preservatives & their sodium salts, method is being reviewed for adoption by the EP.
• Reviewed, conducted, and evaluated over 200 equivalency and superiority studies of
analytical methods to determine compliance to published guidelines such as International
Conference on Harmonization (ICH) USP and FDA
• Oversaw the stability analytical method improvement project: evaluated analytical methods
for all company drug products, drug substances and registered intermediates, rectifying
deficiencies in method validation and generating data necessary to bring methods in
compliance.
MERCK AND COMPANY, WEST POINT, PA 1997-1999
Stability Analyst, Manufacturing Division-Quality
Provided technical and regulatory guidance and oversight for all API and pharmaceutical products
with stability information for regulatory filings, registrations, and re-registrations, such as annual
reports, new drug applications (NDAs) and change being effected (CBE) reports. Reviewed
submissions and responses to regulatory agencies worldwide from a stability perspective. Provided
leadership and guidance for all Merck Manufacturing Division stability programs. Maintained stability
and expiry information on all Merck products. Conducted statistical evaluation of product stability
data for shelf life determination and justification of extension or contraction of product shelf life.
Developed and drafted stability protocols to ensure product quality and proper expiry requirements
were met.
• Developed and tested stability program ensuring ICH and FDA regulations and compliance
were met and maintained at 30 locations globally
• Reviewed expiry periods, control and release specifications, and label storage statements.
Supported Global Facilities Plan initiatives.
• Provided stability support for new product introductions and in-line extensions,
• Provided registration data for over 100 regulatory submissions, annual reports and stability
submissions to keep Merck product registrations current worldwide.
MERCK AND COMPANY, WEST POINT, PA 1996-1997
Staff Scientist, Manufacturing Division-Quality, Analytical Methods and Support
Performed routine and non-routine physical and chemical tests on raw materials, active
pharmaceutical ingredients, in process and finished products, and excipents. Performed testing for
support of product registrations. Performed cleaning method validations to support manufacturing
sites. Assisted manufacturing sites worldwide with Out of Specification and Atypical laboratory
investigations including processing problems. Assisted regulatory group with responses to worldwide
regulatory agency questions and requests. Developed and validated analytical methods and tests to
determine product quality.
• Reduced redundant laboratory testing of compendial methods by 1/3 by reviewing, and
evaluating equivalency and superiority studies of analytical methods while keeping
compliance to worldwide compendial guidelines
• Developed a photographic guide for TIMOPTIC XE ocumeter customer complaints, reducing
the time and effort necessary to examine customer returned products for defects or
tampering.
PAGE 3 DAVID H. MEISER
• Contributed to the drug substance physical characteristic project, validating and generating
data on API physical characteristics (Particle size, Surface Area, X-ray powder diffraction) to
develop specifications all Merck drug substances.
• Tested over 500 “customer complaint” investigations from manufacturing and customer
returns for potential defects and manufacturing process & manufacturing issues to determine
the root cause for the problem associated with each “complaint”
ADDITIONAL EXPERIENCE
Mobile Oil Corporation Analytical Chemist Toxicology
Mobil Research and Development Corporation Organic Synthesis Chemist
Union Camp Corporation Laboratory Scientist, Terpenes and Aromatics
EDUCATION
Bachelor of Science, Delaware Valley College, Doylestown, PA
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