Chris Ott Email & Phone Number

Extensive experience in Quality Operations Management of drug development, manufacturing, manufacturing investigations, commercialization and regulatory approval in a matrix managed environment. Have been responsible for all quality events, investigations and CAPAs at a GMP facility after putting quality systems in place. Significant experience in management of relationships with contract manufacturers and testing laboratories. Have managed cross-functional teams in OOS, manufacturing problems, quality investigations for U.S. and ex-U.S. drug programs and PAI readiness. Have audited API and DP Contract Manufacturers and Quality Control Laboratories for compliance to the regional cGMP in the US, Canada, Europe and Japan. Have written CMC sections for NDAs, NDA Updates, NDA Annual Reports, PASs, INDs, IND Amendments, IND Annual Reports, FDA Requests for Information responses, CTAs and MAAs. Have set up and managed stability, bioanalytical and Quality Control laboratories. Accomplished analytical research scientist with knowledge of formulations, drug stability, product characterization, bioassay, mass spectrometry and traditional separation techniques (including HPLC and CE). Managerial experience in both industrial (QA Group and QC, bioanalytical and contract cGMP QC laboratories) and academic settings. Extensive teaching, training and mentoring experience.

Listed skills include Ind, Regulatory Submissions, Capa, Gmp, and 6 others.