Director - Vaccine Research- Analytical Development @ From October 2009 to Present (6 years 3 months) Director of Early Phase Analytical Development @ • Manager of 5 analytical development laboratory groups with a total of 23 reporting staff. Responsibilities of my organization include supporting protein and polysaccharide conjugates analytical method development, method qualification, method transfer and testing of drug substances and drug products in support of early phase toxicology studies.
• Provide analytical characterization support to the Bioprocess and Development group during purification optimization to help gain process understanding.
• Analytical methodologies include RP- HPLC, size- exclusion chromatography with light scattering detection (SEC-MALLS), Ion-Exchange Chromatography (IEX), Amino Acid Analysis (AAA), Capillary Electrophoresis (CE), Bioplex immunoassays (in-vitro potency), Slot Blot, Western Blots, Nephelometry, LC/MS and GC/MS.
• Participate on multi-functional project development teams for key Vaccines programs (early phase through post approval) From April 2009 to October 2009 (7 months) Associate Director (Analytical Development) @ •Manager of an analytical development laboratory with a total of 16 reporting staff supporting method development, validation and testing of drug substances and drug products (oral and IV) from pre-IND through NDA.
•ARD project representative for development projects on multi-displinary project teams
•Actively involved in reviewing and compiling regulatory documents and responses
•Participated in pre-approval inspection preparations and pre-approval inspections of manufacturing and analytical testing sites
• Maintained and operated under cGMP conditions.
• Responsible for development and validation of purity, and strength (chiral and non-chiral) methods for investigational drug substances.
• Analytical method support for formulation development, including strength, degradation, content uniformity, dissolution and absence of active in placebo From February 1999 to April 2009 (10 years 3 months) Research Scientist @ • HPLC method development, validation, and writing of test protocols for assays, content uniformity, dissolution and impurity analysis under GMP and FDA regulations. USP methods and SOPS followed.
• Involved in setting up and maintaining a Waters Thermabeam LC/MS for impurity analysis. From May 1998 to February 1999 (10 months)
Ph.D., Chemistry @ Princeton University From 1993 to 1998 B.S., Chemistry @ Binghamton University From 1989 to 1993 Lynn Phelan is skilled in: Chromatography, HPLC, Analytical Chemistry, LC-MS, Vaccines, Immunoassays