Senior Consultant, Biologics Consulting Group, Inc.
Potomac, MD.

• Evaluate client CMC scientific and regulatory strategies for a wide range of therapeutic drug products (biologic and non-biologic) formulated in a variety of dosage forms, at all stages of product development, from pre-IND through post-NDA approval.
• Provide regulatory strategies for combination products (drug/device, biologics/device).
  
• Review and provide advice on IND and NDA submissions for suitability relative to FDA expectations for CMC data.
  
• Perform gap analysis audits for deficiencies relative to FDA expectations.
  
• Conduct regulatory and scientific due diligence audits for business acquisitions and licensing partnerships. Provide assessment of strengths and deficiencies.
  
• Represent clients in interactions with FDA.
  
• Represent client as FDA regulatory expert in legal proceedings.
  
• Prepare and write submissions to FDA, with focus on CMC sections.
  
• Provide scientific and regulatory training and presentations at pharmaceutical/biopharmaceutical conferences.
  

Division Director (acting) March 2004 - Dec. 2004, Deputy Division Director (acting) July 2003 - March 2004. FDA, CDER, Office Of New Drug Chemistry, Division Of New Drug Chemistry III. Rockville, MD.

• Supervised 34 employees in 9 therapeutic product classes, includes 6 Team Leaders, review chemists and administrative staff.
  
• Planned and set long-range plans and schedules for Division work. Directed and coordinated workload, and assured implementation of Division policies, goals and objectives.
  
• Made critical decisions and provided expert advice concerning regulatory and scientific approaches and options consistent with Office policies and objectives.
  
• Evaluated budget and fiscal controls to manage Division functions.
  
• Evaluated Team Leader and review chemist performance.
  
• Performed tertiary reviews of NDAs for new molecular entities.
  
• Represented FDA in dealing and negotiating with the regulated industry, and professional and industry organizations.
  
• Participated as invited speaker at regulatory and scientific conferences.
  
• Served as the Chair of the Stability Guidance Technical Committee, Co-chair of the Conjugated Estrogens Working Group and CO-chair of the Good Review Practices Working Group.

Lead Chemist (Team Leader), FDA, CDER, Division Of Reproductive and Urologic Drug Products. Rockville, MD.

• Managed a team of 4 review chemists in 2 therapeutic product classes.
  
• Responsible for secondary review, consistency of CMC reviews and adherence to FDA/ONDC policies and guidances.
  
• Coordinated reviewers' workload of IND and NDA submissions to ensure that reviews were conducted in timely manner.
  
• Extensive interactions with the regulated industry to provide regulatory direction during IND drug development and NDA post-approval activities.
  
• Active in the development of FDA guidances for industry and internal good review practices. Served as the Chair of the Stability Guidance Technical Committee, CO-chair of the Conjugated Estrogens Working Group and CO-chair of the Good Review Practices Working Group.

Chemistry Reviewer, FDA, CDER, Division Of Reproductive And Urologic Drug Products. Rockville, MD.

• Evaluated the quality of new drug products submitted to the FDA for approval.
  
• Integral part of a review team responsible for evaluating the quality and effectiveness of reproductive and urologic drug products being investigated in clinical studies.
  
• Major contributor to committees responsible for establishing drug product quality standards and publishing guidances for pharmaceutical companies.
  
• Provided regulatory guidance to pharmaceutical company representatives during drug product development through direct face-to-face meetings.
  
• Mentored new reviewers.
  
• Served as computer focal point to facilitate and troubleshoot computer issues.

National Research Council Fellow, FDA, CBER, Laboratory of Parasitic Biology and Biochemistry. Bethesda, MD

• Investigated the biological role of specific proteins in the sexual differentiation of the malaria parasite. Published three research papers in peer-reviewed journals.
  
• Presented research data at three separate scientific conferences.
  
• Supervised the research projects of college students.
  
• Responsible for the coordination of instrument repairs and the ordering of laboratory supplies.
  

Staff Scientist, General Electric Co., Corporate Research & Development, Biological Sciences Laboratory. Schenectady, NY.

• Developed recombinant biphenyl-metabolizing microorganisms capable of degrading environmental contaminants. Marketed this technology to the GE business units and government agencies responsible for environmental clean-up.
  
• Investigated the factors affecting aerobic biodegradation of indigenous PCBs in Hudson River sediment by various bacterial strains.
  
• Isolated and conducted mechanistic studies of the dioxygenase enzymes involved in biodegradation.
  
• Investigated the scientific and economic feasibility of biologically synthesizing aromatic monomers for use as a feedstock to produce biodegradable polymers.
  
• Supervised research projects of summer interns.
  
• Published research in peer-reviewed journals.
  
• Recruited at major East Coast universities. Interviewed and screened graduating science Ph.D. students for second round interviews at the Research Center.

Research Assistant, University of Maryland, Dept. of Chemistry/Biochemistry. College Park, MD.

• Investigated mechanism of action of two bacterial enzymes, mandelate racemase and D-amino acid oxidase.
  
• Synthesized and tested novel halogenated aromatic hydroxy- and amino- acid analogs as potential irreversible inhibitors.
  
• Published research in peer-reviewed journals and co-authored one chapter in a biotechnology book. In addition, the research data was presented at two national scientific conferences.
  
• Served as the computer expert for the laboratory group.
  

N.R. Schmuff and D.T. Lin, “Contents of Module 3 for an Electronic Common Technical Document Investigational New Drug Application,” in Preparation and Maintenance of the IND Application in eCTD Format, W.K. Sietsema (ed.), FDAnews, Falls Church, VA, 117-134 (2008).

N.R. Schmuff and D.T. Lin, “Chemistry, Manufacturing and Controls (CMC),” in Wiley Encyclopedia of Clinical Trials, (2008).