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Bioanalytical Expert: Large Molecule, PK, PD, and Immunogenicity Assays under GLP and GCP Guidance Consulting

Technical Consultant #2530


Expertise

Summary 

Accomplished bioanalytical scientist with extensive and diverse experiences in biotechnology and pharmaceutical industries.  Strong reputation for planning and organizing, analytical problem solving, multi-tasking. and coordinating team efforts.  Creative, collaboration and highly goal-driven scientist. 

  • Expert in Ligand Binding Assays including immunogenicity.
  • Successfully implemented complex acid dissociation ADA methods. 
  • Strong working knowledge of 21 CFR part 58. 
  • Over 20 years working in regulated bioanalysis. 
  • Management of non-clinical and clinical programs at a bioanalytical laboratory. 
  • Assist in the vetting and ultimate selection of a bioanalytical laboratory. 
  • Experience in multiple modalities including ADCs, fusion, PEGylated, and endogenous proteins. 

 Focused Areas

  • Ligand Binding Assays for Pharmacokinetics (PK), Pharmacodynamics, (PD) and Anti-Drug Antibodies, (ADA) methods.
  • ELISA: absorbance, luminescent, and fluorometric.
  • Meso Scale Discovery (MSD): PK, PD, and ADA methods.
  • Immunogenicity: bridging methods, direct methods, acid dissociation methods.
  • Method Validation: following most recent guidance.
  • Bioanalysis: planning dilutions and assisting in managing flow.
  • 21 CFR part 58/GLP: application for the bioanalytical lab.
  • Biomarker: screening exploratory and Fit-For-Purpose Validations.
  • SOP writing and review: for the biopharma LBA space.
  • Design of Experiments: statistical design of experiments.
  • Report and plan review: for content, readability, and compliance.
  • Review of CRO capabilities for desired work.
  • Generation of RFQ questionnaires for contract labs.
  • Implementation of automation in a bioanalytical lab and ADA methods.

Experience

S,B.C., President-Owner, 2020 - Present

  • Partnering to develop bioanalytical strategies and enable successful drug development.
  • Develop and review questionnaires for selection of contract labs.
  • Coordinate method development with laboratory.
  • Review procedures, SOPs, reports for inclusion in final study reports.
  • Coordinate and manage reagent generation programs.

K.B.B.S., Shawnee, KS, 2017 - Present

Director of Bio-Pharma Services

  • Progressive organization providing reliable and defendable data to enable clients to improve health worldwide.
  • Increased annual revenue from $2 million to $8 million in less than 3 years.
  • Grew department from 5 individuals to a team of over 25.
  • Generated departmental updates for executive management quarterly board reports.
  • Directed regular forecasting meetings with principal investigators to ensure accuracy.
  • Collaborated with QAU to develop fully compliant large molecule bioanalytical lab.
  • Supervise staff in method development, validation, and production sample analysis.
  • Mentor and coach junior staff.
  • Develop departmental strategy for growth and success.
  • Serve as technical resource for method development and troubleshooting.
  • Coached ADA method development to achieve ~20-fold increase in drug tolerance.
  • Consulted on multiple PEG related programs including anti-PEG antibody assays.

AIT Bioscience, LLC,  Indianapolis, IN, 2015 - 2017

Group Leader  Ligand Binding Assay Department (LBA)                                   

  • State of the art contract research organization committed to innovation and operational excellence in support of bioanalysis.
  • Supervise staff in method development, validation, and production sample analysis.
  • Managed operations of LBA group.
  • Responsible for collation of weekly revenue forecasting.
  • Scientific contact for business development and critical client interactions.

Pfizer Incorporated, Groton, CT, 2007 - 2015

Senior Scientist - Pharmacokinetics and Drug Metabolism, Andover, MA, 2011 - 2015  

  • A global pharmaceutical company committed to helping people improve their health by discovering and developing medicines.
  • Promoted to expanded responsibilities.
  • Supervise contract employees in regulated bioanalytical laboratories.
  • Manage bioanalytical portions of non-clinical studies as Principal Investigator.
  • Manage operational functions of a core automation team.
  • Develop and validate bioanalytical methods for quantification of therapeutic and detection of anti-drug antibodies in matrix.
  • Perform sample analysis for regulated pre-clinical studies.
  • Transfer methods and monitor analytical work performed at CROs.
  • Active participant in technology assessment team.
  • Mentor junior colleagues.

Scientist - Pharmacokinetics and Drug Metabolism, Andover, MA, 2010 - 2011

  • Relocated following re-organization.

Scientist - Pharmacokinetics and Drug Metabolism, Groton, CT, 2007 - 2010

Amgen Incorporated, Thousand Oaks, CA, 2005 - 2007

  • A global biotechnology company discovering, developing, manufacturing and marketing novel human therapeutics based on advances in cellular and molecular biology.

Curagen Corporation, New Haven, CT, 1999 - 2004

  • Genomics-based pharmaceutical company focused on development of novel antibody, small molecule, and protein therapeutics.  

Honors & Publications


Credentials 

  • Computer Skills:  Watson LIMS, IDBS Biobook suite, JMP, Design Expert, SigmaPlot, Softmax Pro, Adobe Acrobat.

Academic and Professional Affiliations

  • American Association of Pharmaceutical Scientists
  • BioKansas

Publications and Patents 

  • Multiple publications from the Global CRO Council
  • Published in multiple bio-analytical specific journals including Bioanalysis, Journal of Immunological Methods, and the AAPS Journal
  • Co-author on a paper featured on the cover of Science.
  • Co-author on multiple abstracts and posters presented at a variety of professional conferences.
  • Podium presentations discussing statistical design of experiments, and innovative LBA technologies. 

Education

  • M.S.  Quality Assurance and Regulatory Affairs, Temple University, Fort Washington, PA
  • B.S.   Microbiology, Ohio University, Athens, OH
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