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

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