Pharmaceutical and Biotechnology Analytical Chemistry Expert - Lean cGMP, QC Testing

Technical Consultant #2086


Expertise

  • Analytical, biochemical, microbiological, and raw material cGMP testing laboratories.
  • Implementation of robust quality systems including, test method validation and transfer, Out Of Specification (OOS) investigations, product stability program, LIMS, training program, document control, specifications, equipment qualification, raw material qualification, risk assessment, Corrective And Preventive Action (CAPA), nonconformance investigations, and performs internal and external (vendor, contract lab, client) audits and supports regulatory inspections.
  • Test method development, validation, transfer, and troubleshooting, techniques include High Performance Liquid Chromatograpy (HPLC) and Ultra Performance Liquid Chromatograpy (UPLC), Gas Chromatography (GC), Karl Fischer, Ultra Violet (UV) and Visible Radiation (Vis), Fourier Transform Infrared Spectroscopy (FTIR), wet chemistry, BCA, SDS-PAGE, dissolution, ELISA, qPCR, immunoblot, genetic sequencing, flow cytometry, microbial recovery and enumeration (suitability), and preservative effectiveness (AET).
  • Diverse product testing and manufacturing support including, injectable (lyophilized, liquid) drugs and biologic, oral drug (tablets, capsule, thin film), combination device and drug, OTC topical and cosmetics products.

Experience

Undisclosed Firm, Owner, Present

  • Management of quality operations to support GMP product manufacturing clients.
  • Provide analytical, microbiological, and biochemical test method development, method validation, and method transfer to support raw material, in process, stability sample, finished product, release testing, including data review, and product release.
  • Establishes, directs, and performs quality functions including stability studies and stability testing, material qualification and vendor qualification, vendor audits, change control, risk assessment, cleaning validation, OOS investigations, and equipment qualifications.
  • Authors, reviews, and approves technical documents including test method validations studies, laboratory investigations, specifications, work instructions, standard operating procedures, test methods, risk assessment, deviation, process validation protocol and validation report, and provides regulatory filing support.
  • Technical resource and liaison for manufacturing process improvement, product development, investigations, and regulatory submissions.

Biovest International, Minneapolis, MN, Quality Control Manager, 2014 - 2015

  • Developed GMP laboratories and manages technical staff supporting European marketing application of novel cancer vaccine.
  • Authors, reviews, and approves protocol/reports and directs activities for more than 20 test method validation projects using many techniques, including UV and Vis, BCA, immunoblot, SDS-PAGE, HPLC/UPLC, ELISA (qualitative and quantitative), flow cytometry, and next generation genetic sequencing.
  • Establish and support quality system elements including OOS investigations, equipment qualifications, product stability program, raw material qualifications, reference standard qualifications, process validation, QP site inspection, and vendor audits.

Apex International, Chaska, MN, Quality Control Manager, 2011 - 2014

  • Developed GMP laboratories and manages more than 20 technical staff and directs activities in raw materials, in-process QC, analytical and analytical development, stability, and microbiology areas spanning two facilities.
  • Developed and implemented quality systems for GMP compliance, including ICH product stability program, deviations, CAPA, OOS investigations, test methods validation, raw material qualifications, cleaning validations, and analyst training.
  • Performs investigations to resolve GMP manufacturing, product development and stability, and test method validation failures.

Pace Analytical, Oakdale, MN, Group Leader and Principal Chemist, 2010 - 2011

  • Supervised for 6-12 analysts engaged in GMP contract testing of finished pharmaceutical and device and combination products.
  • Conducted laboratory OOS investigations, analyst training, and test method performance troubleshooting.
  • Performed and directed laboratory actives in support of method development, validation, and transfer studies to support cleaning verification and finished product testing (including moisture, dissolution, uniformity, assay, impurity/degradation tests).

Hollister Stier, (Jubilant Hollister Stier), Spokane, WA, Senior Scientist, 2006 - 2010

  • Supervisor of a team of analysts in the method transfer and validation group conducting laboratory activities in support of contract manufacturing projects. Conducts laboratory OOS investigations, analyst training, and helped resolve many technical challenges associated with manufacturing, stability, method development/transfer/validations, product failures, and test method performance.
  • Quality representative on many cross-functional project teams for contract manufacture of clinical trial and commercial products.
  • Performed and directed laboratory actives in support of method development, validation, and transfer studies, stability, release testing, and investigations.

King Pharmaceuticals,Rochester, MI, Analytical Development Scientist, 2004 - 2006

  • Performed test method development and validation activities for assay, stability, cleaning verification, container closure integrity (dye egress), and particle size methods for regulatory submission.
  • Examined and solved technical challenges associated with methods validation, contract manufacturing, product stability, and cleaning verification.
  • Developed and validated custom calculations for automated reporting of results from HPLC analysis.

Cargill, Eddyville, IA, Quality Control and Quality Assurance Chemist, 2002 - 2003

  • Performed sampling and GMP testing of raw materials, in-process, and finished products using a variety of analytical techniques and performed methods validation activities.

3M, University of Minnesota, MN and Central Michigan University, MI, 2000 - 2004
Positions
Technical Aide, 2000 - 2002
Undergraduate Research Assistance, 2001 - 2002
Graduate Research Assistant, 2003 - 2004

  • Established NMR spectra databases and operated liquid and solid state NMR spectrometers for evaluation of polymeric and protein samples.
  • Conducted spectral analysis of complex multi-dimensional NMR experiments to determine unknown samples and authors and review technical.

Honors & Publications

Credentials

  • GMP Auditor Training (FivePharma)
  • Lab Leadership and Management (UC Davis, Extension)
  • Certification of Regulatory Affairs in a Technical Environment, Lehigh University
  • Lean Six Sigma Green Belt. Streamline of Analytical Method Transfer Activities

Publications

  • Author and Co-Author of peer reviewed text.

Education

  • M.S. Chemistry, Lehigh University, Bethlehem, PA
  • B.S. Chemistry, University of Minnesota Twin Cities, Minneapolis, MN
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