Chris Ott Email and Phone Number
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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.
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Director Quality AssuranceSumitomo Pharma America Jul 2023 - PresentMarlborough, Massachusetts, UsSunovion Pharmaceuticals Inc is now Sumitomo Pharma America, Inc. (SMPA). I’m pleased to be joining SMPA on this new journey. I look forward to contributing to our mission and making a difference in patients’ lives. Follow our LinkedIn www.linkedin.com/sumitomo-pharma-america to learn more.
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Director Of Quality AssuranceSunovion Pharmaceuticals Inc (Formerly Sepracor, Inc.) 2003 - Jul 2023Marlborough, Ma, Us -
Sr. DirectorOmega Pharmservices 2000 - 2002
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Manager Of StabilityHybridon 1993 - 2000
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Associate Professor Of ChemisryAssumption College 1985 - 1993Worcester, Massachusetts, Us
Chris Ott Skills
Chris Ott Education Details
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College Of The Holy CrossChemistry -
University Of California, DavisChemistry
Frequently Asked Questions about Chris Ott
What company does Chris Ott work for?
Chris Ott works for Sumitomo Pharma America
What is Chris Ott's role at the current company?
Chris Ott's current role is Director of Quality Assurance at Sumitomo Pharma America.
What is Chris Ott's email address?
Chris Ott's email address is ch****@****ion.com
What is Chris Ott's direct phone number?
Chris Ott's direct phone number is 508-481-*****
What schools did Chris Ott attend?
Chris Ott attended College Of The Holy Cross, University Of California, Davis.
What skills is Chris Ott known for?
Chris Ott has skills like Ind, Regulatory Submissions, Capa, Gmp, V&v, Fda, Analytical Chemistry, Validation, Sop, Technology Transfer.
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