pdf_button
Print  pdf  email

Biopharmaceutical Product and Process Development Expert Resume

Resume of WHN, Ph.D. Consultant
Principal Industries Served:
  • Biotechnology
  • Chemicals
  • Food Processing
  • Health and Beauty Aid Products
  • Medical Devices and Equipment
  • Packaging
  • Pharmaceuticals

Education:

This expert has a Ph.D. in Genetics from St. Petersburg State University.


Expertise and Services:

Biopharmaceutical Product and Process Development Expert Resume

This expert specializes in product and process development, including knowledge of moving biopharmaceutical products through an R&D pipeline to manufacturing, IND filing and clinical trial.

This consultant's experience includes establishing a project team, managing product development process at all levels, and design of product certificates of analysis. This consultant has hands-on-experience with initial analytical assay development through establishment in QC, regulatory submissions; project management: proposal preparation, planning, reporting, budgeting, staffing, regulatory IND and DMF filing for new biopharmaceutical products.

Additional capabilities include lab management encompassing functional molecular biology lab setup, supervising, and training. In the molecular biology field, this expert specializes in nucleic acids assay development and validation-GMP (good manufacturing practice) assay development for characterization of pharmaceutical products, such as DNA genotyping, plasmid DNA forms, plasmid DNA identity, plasmid or gene copy number. Further specialties include levels of residual RNA, residual host chromosomal DNA, assay validation according to FDA and ICH guidelines, and assay transfer and establishment in QC. Relevant expertise in the field of DNA diagnostics/molecular genotyping include PCR, RFLP, SSCP, allele-specific PCR, allele-specific hybridization and Southerns. In recombinant DNA, this expert specializes in litigation, transformation, electroporation, and clone screening. In regards to microbial genetics this expert specializes with all essential microbiological techniques including random and site-directed mutagenesis, mating and mapping, constructing strains of desired genotype, and transformation and maintenance. Furthermore experience includes clone screening, yeast two-hybrid system, and yeast tetrad analysis. This expert is highly skilled in regards to protein expression concerning yeast and bacterial vector construction, secretional and intracellular expression of recombinant proteins in yeast, Northerns, Westerns and recombinant protein purification. In protein chemistry this expert specializes in size fractionation, ion exchange chromatography, affinity chromatography, enzymatic assays, and spectrofluorimetry. This expert also has experience teaching and training.


Professional Experience:

Consultant, Kevin Kennedy Associates Inc.

Providing project management and consulting services to the pharmaceutical, life sciences, biotechnology industries, with specialization in molecular biology, and related expertise to a wide variety of clients.

 

Scientist II, Scientist I, Specialist II, vaccines and diagnostics firm

Head of the Nucleic Acids Assay Development group. Analytical project management in biotechnology GMP environment. Designed and developed a variety of novel DNA and RNA analysis methods, validated assays according to ICH guidelines. Prepared SOP (standard operating procedure) protocols, transferred assays to QC. Established a solid and unique analytical platform for characterization of DNA-based pharmaceutical products according to FDA guidelines. Coordinated and oversaw all analytical activities required for product characterization and release. Designed certificates of analysis for the nucleic acid-based products. Composed analytical parts of the IND package for FDA filing. Prepared NIH grant proposals for HIV DNA Vaccine. Supervised and trained staff members in the execution of DNA and RNA analysis procedures.

 

Post-Doctoral Staff Member, Biology and Biotechnology Research Program, Lawrence Livermore National Laboratory, CA

Designed and constructed novel vectors for protein expression in yeast Saccharomyces. Expressed and characterized human XPA and XRCC1 DNA repair proteins.

 

Visiting Scientist / Consultant, Department of Virology, University of Turku, Finland

Established a PCR-based DNA genotyping platform for determining genetic predisposition to insulin-dependent diabetes mellitus, multiple sclerosis and rheumatoid arthritis.

 

Assistant Professor, Department of Medical Genetics, St. Petersburg Pediatric Medical Institute, Russia

Delivered series of lectures, instructed and trained medical students in theoretical and practical approaches to DNA diagnostics of human inherited diseases. Trained and supervised a group of researchers to investigate genetic nature of predispositions to human diseases, and to develop methods for DNA diagnostics.

 

Ph.D. Candidate, Laboratory of Genetics of Eucaryota, Petersburg Institute of Nuclear Physics, Russia

Discovered that spontaneous conversion events in yeast mitosis involve extended regions of yeast chromosomal DNA.

 

Research Associate, Laboratory of Biochemical Genetics, St. Petersburg State University, Russia

Purified and characterized phosphoribozylaminoimidazole carboxylase from yeast Saccharomyces cerevisiae.

Case Studies:

Quantitative RFLP: A Procedure for Quantitation of Diphtheria Toxin Gene CRM197 Allele


engineering-analysis-guide

FEATURED EXPERT

Peter Habicht, Lead Consultant
Peter specializes in welding and metallurgical engineer with 40 years industry experience in commercial nuclear power plant construction, specialty metals manufacturing,

FEATURED ARTICLE

Construction Consultants
We have consulting experts able to provide solutions in composites manufacturing and design and a complete range of related materials science applications.

RAPID RESPONSE

Our Business Model
At Kevin Kennedy Associates, we’ve revolutionized the consulting business by streamlining the way our clients interact with experts.