Technical Consultant

Biopharma Technical Consultant with over 10 years’ analytical experience with biotherapeutics spanning peptides to cell therapy and subject matter expert for assay development and validation. Extensive experience with HPLC, MS, electrophoresis, protein quantitation, and visual inspection assays with recent expansion into bioassays. Detailed technical project manager leading with industry knowledge and transparency.

Core Competencies

  • Analytical Development:

    • Manage assay development, validation, and technology transfer activities

    • Identify Quality Attributes and phase-appropriate test strategy

    • Support CRO/CDMO selection and manage relationships for productive collaborations

    • Design laboratory spaces and drive operational readiness

    • Support laboratory and result investigations

    • Develop Quality Target Product Profiles and Control Strategies

  • Project Management:

    • Map out project timelines and milestones

    • Create and maintain project trackers and collaborative workspaces

    • Identify gaps and gates in on-going projects

    • Foster open and transparent communication channels

    • Guide consensus decisions from cross-functional teams

  • Technical Writing:

    • Create, compile, and convey technical material in a concise and effective manner

    • Write, edit, and publish scientific, regulatory, and technical documents

 

Photo Jun 27, 4 39 54 PM.jpg

Experience

Technical Consultant, DQV Bioanalytical, LLC

  • Assay performance review and assessment against current industry standards and regulatory expectations with focus on patient safety

  • Manage relationships between CTLs and small biopharma from MSA review through project completions, including method transfer and product testing

  • Draft technical and regulatory documents, including process/product control strategies, high-level facility overviews, and procedure reviews

  • CMC package review for potential asset acquisition

  • Develop target analytical profiles and provide equipment recommendations for recombinant protein and C&GT products

  • Provide training, technical guidance, and trouble-shooting assistance

  • Provide Mass Spectrometry subject matter expertise

Senior Scientist, Catalent Cell & Gene Therapy

  • Manage Analytical team for recombinant vaccine process characterization, responsible for ensuring prompt deliverables through inter-departmental teamwork

  • Lead Separations Team within Analytical Development, requiring flexible management styles with time and resource management

  • Coordinate with Quality Control for method qualification and tech transfer

  • Responsible for laboratory equipment and lab setup as part of multi-department team

Scientist II, Novavax

  • Execution of forced degradation and other product characterization studies

  • Method development of HPLC-MS/MS characterization of adjuvant saponins

  • In-process testing: oligosaccharide profiling, IDMS, and peptide mapping

  • Document generation: test methods, SOPs, study protocols, & technical reports

  • Supervision of interns and Ph.D. students

  • Active member of safety committee and lab chemical hygiene officer

Education

Post-doctoral research | Utrecht University 2014

Ph.D. | University of North Carolina at Chapel Hill                                                                              2010

B.S. | Georgia Institute of Technology                                                                                                     2006