Veeva
Andrew Weishar
Hickory,North Carolina
Work Preference
Overview
20
20
years of professional experience
8
8
years of post-secondary education
Work History
Analytical Research & Development Supervisor Sterile Pharmaceutical Manufacture
Exela Pharma Sciences LLC
Lenior, NC
01.2022 - 01.2026
- Supervise a team of three (3) Senior Scientist in the Development and Validation of Analytical methods for use in the R&D department and transferring to the Quality Control Lab for release and stability testing
- Maintain employee development and performance reviews for yearly reviews
- Review draft methods, protocols and reports for Scientist in R&D
- Approve final methods, protocols and reports for Scientist in Veeva electronic document system
- Write and approve method and protocol deviations for Scientist when necessary
- Help Scientist by writing methods, protocols and reports
- Write Change Controls for method transfers to the QC Lab
- Help R&D with Extractable and Leachable stability testing on new products for FDA submission for approval
- Write Final Extractable and Leachable reports
- Preform Method Development and Validation when needed to help R&D
- Investigated laboratory exceptions for client samples with QA
- Work closely with the client to ensure results are submitted on time and within limits
Senior Chemist II Contract Labor Organization (CLO)
Eurofins
Winston-Salem, NC
01.2019 - 01.2022
- Perform analysis and validation of HPLC methods for new products for the client
- Analysis Client samples using HPLC/MS/MS
- Prepare and execute Protocols for new product method evaluations
- Improve and Validate production clean in place (CIP) HPLC methods
- Administer support for LIR investigations and method improvement through CAPA request for QC
- Represented the LC Lab with the Method Development group on new HPC method transfers and validations of new HPLC methods for new products for the client
- Investigated laboratory exceptions for client samples with QA
- Work closely with the client to ensure results are submitted on time and within limits
Scientist IV Contract Manufacturing Organization (CMO)
Patheon a division of Thermo Fisher Scientific
High Point, NC
01.2014 - 01.2019
- Perform new instrumentation, encompassing the Hand-held Raman for Raw Material release
- Developed and improved customer methods for HPLC/GC and Particle size
- Prepare and execute Protocols for new and updated USP monograph method evaluations
- Preform method transfers and validation protocols for new customer HPLC/GC methods for the QC Lab
- Improve and Validate production clean in place (CIP) HPLC methods
- Administer support for LIR investigations and method improvement through CAPA request for QC
- Represented QC on a production Mini-T for equipment cleaning verification to include HPLC method improvements and revalidation and preformed multiple cleaning verification samples
- Investigated a finished product failure and realized the method was not linear below the methods standard concentration helped redevelop the method and revalidate
- Assumed responsibility for the calibration and maintenance of the Dissolution baths for the metrology group while they were understaffed
- Transferred and validated API and Finished product Particle size methods using the Malvern Mastersizer 2000 with a Hydro unit
Method Development Scientist Contract Manufacturing Organization (CMO)
PCI
Newburyport, MA
01.2012 - 01.2014
- Perform new instrumentation, encompassing Charged Aerosol Detector (CAD) with HPLC
- Capitalize on industry expertise in developing user guide for the setup, shutdown, and cleaning and maintenance of the CAD instrument, along with standard operating procedure (SOP) for the calibration of the CAD instrument
- Establish analytical methods for customers products for scale up from research to production
- Prepare protocols for validation and the validation reports per GMP regulations and FDA guidelines
- Administer the development of more than 15 methods for a 5-step in-process
- Employ UV-Vis, GC, and HPLC and the validation protocols and validation reports including rinse and swab samples in creating cleaning validation methods
- Led the accomplishment for product for a customer, including HPLC CAD and GC headspace methods for residual solvents
- Gained recognition as subject matter expert for the CAD; assigned to work on two CADs on existing HPLCs
- Played a key role in developing an HPLC assay and purity method for a new compound with very little information from the customer
Senior Associate Scientist
Pfizer, Global R&D, Groton Analytics
Groton, CT
01.2010 - 01.2012
- Leveraged skills in testing active pharmaceutical ingredients, solid dose drug product, and raw materials using various USP and EP methods for GMP Quality Control release
- Accurately identified raw materials for release and use in the kilogram laboratory through proper application of handheld Raman TruScan 785nm spectrophotometer and Bayspec 1064 nm spectrophotometer
- Utilized UV/Vis, GC, and LC-MS in developing clean by test (CBT) methods for active pharmaceutical ingredients (APIs) for the kilogram laboratory
- Encoded all tests report and procedures performed in the laboratory through Symyx Notebook
- Played a major role in setting up and testing the handheld Raman used in raw material release for the kilogram laboratory within receiving, eventually expediting the release time of a material
- Completed the complex analysis of the handheld Raman as a replacement for the PXRD in identifying the crystalline form of Active Pharmaceutical Ingredients (API), along with its use as the identity testing for excipients and post-pack in solid drug products
- Gained comprehensive knowledge in testing finished solid dose drug products and differences from API release
- Ensured safety of drug for extended period of time and its various storage conditions employing broad understanding of stability protocols and necessary testing procedures
Senior Associate Scientist
Pfizer, Global R&D, Supply Chain Analytical Control
Groton, CT
01.2006 - 01.2010
- Facilitated the testing of APIs in-process and finished samples from the R&D research kilogram laboratory for assay and potency using HPLC and various USP and EP methods, assuring compliance with Pfizer and Food and Drug Administration (FDA) guidelines for release into clinical and stability protocols
- Utilized various USP and EP methods for Quality Control GMP release in experimenting active pharmaceutical ingredients and raw materials
- Made use of Waters Empower software in running and processing HPLC sequences on Agilent 1100 systems
- Performed complex testing on in-process control samples for the Kilo Lab with off shift and weekend support
- Delivered exemplary service in performing spectra scans through an Oxford AS/400 NMR with VNMR software and ACD/SpecManager 9.0 software to ID compounds, along with routine identity scans with the use of a Nicolet Nexus 470 FT-IR with OMNIC version 6.2 software
- Successfully completed training on a Bruker AXS D8 ADVANCE X-ray diffraction instrument to determine crystal form of active pharmaceutical ingredients utilizing DIFFRACplus software as well as on Bruker S4 Explorer X-ray fluorescence instrument for research for heavy metal content
- Accomplished analysis to determine water content applying coulometric/volumetric Karl Fischer
- Engaged in the proficient testing for residue solvents in active pharmaceuticals ingredients using HP 6890N GC with G1888 headspace autosampler and Perkin Elmer Autosystem XL GC with a TurboMatrix 40 Headspace autosampler
- Directly supervised the transfer of cGMP instruments and the installation of new instruments in a new cGMP laboratory
- Ensured availability of all raw materials necessary to manufacture clinical batches of new active pharmaceutical ingredients through close interaction with pilot plant personnel
- Effectively served as point-of-contact for all API raw material testing at Pfizer Global R&D site in Groton
- Obtained proficiency in various methods and instrumentation for testing and release as well as in discovering and identifying path of a new molecule within Pfizer research, including the setup and use of PXRD by a Bruker representative
- Helped in developing UPLC Skin Flux Quantiation method for PF-00251802, PF-04171327, Clobetasol, Propionate, and Hydrocortisone
Summary
I am a Research & Development Supervisor/Scientist with over 25 years of experience in the Analytical Laboratory. For the past 3 years I have worked at Exela Pharma Sciences in Lenoir NC, managing a small group of expert Scientists to develop and validate new analytical methods for our customers. I have developed numerous analytical methods and validated them for use in the QC lab for drug product release. I have also graduated from the New Emerging Leaders course at Exela.
Education
Bachelor of Science - Chemistry Minor in Math
Western Michigan University
Kalamazoo, MI 08.1993 - 05.1996
Master of Science - Chemistry
University of Rhode Island
Kingston, Rhode Island, RI 09.2009 - 05.2012
Bachelor of Science - Chemical Engineering
Michigan Technological University
Houghton, MI 08.1990 - 05.1993
Skills
Laboratory techniques
Scientific writing
Research methodologies
Laboratory experimentation
Performance evaluation
Team collaboration
Continuous improvement
Problem-solving
Analytical thinking
Quality assurance
Analytical skills
Chemical testing
Accomplishments
- Supervised team of three staff members.
- Collaborated with team of five in the development of Antibody-Drug Conjugates.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Affiliations
- ACS American Chemical Society
Quote
When people talk, listen completely. Don’t be thinking what you’re going to say. Most people never listen.
Ernest Hemingway
Software
Empower
Waters_connect
Open Lab
Languages
English
Native or Bilingual
Timeline
Analytical Research & Development Supervisor Sterile Pharmaceutical Manufacture
Exela Pharma Sciences LLC
01.2022 - 01.2026
Senior Chemist II Contract Labor Organization (CLO)
Eurofins
01.2019 - 01.2022
Scientist IV Contract Manufacturing Organization (CMO)
Patheon a division of Thermo Fisher Scientific
01.2014 - 01.2019
Method Development Scientist Contract Manufacturing Organization (CMO)
PCI
01.2012 - 01.2014
Senior Associate Scientist
Pfizer, Global R&D, Groton Analytics
01.2010 - 01.2012
Master of Science - Chemistry
University of Rhode Island
09.2009 - 05.2012
Senior Associate Scientist
Pfizer, Global R&D, Supply Chain Analytical Control
01.2006 - 01.2010
Bachelor of Science - Chemistry Minor in Math
Western Michigan University
08.1993 - 05.1996
Bachelor of Science - Chemical Engineering
Michigan Technological University
08.1990 - 05.1993