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Michael D. is listed as Executive Director, Quality Assurance at Savara Inc., a company with 59 employees, based in Langhorne, Pennsylvania, United States. AeroLeads shows a matched LinkedIn profile for Michael D..
Michael D. previously worked as Sr. Director, Quality Assurance at Annexon Biosciences and Principal Quality Consultant at Mbs. Michael D. holds Bachelor'S Of Science, Analytical Chemistry from Csu Sacramento.
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Focused, quality-driven leader & scientist with significant global strategic QC\R&D\QA\Regulatory experience within medical device, small molecule and biologics sectors. Principal level Analytical Chemist/Scientist with a broad range of small molecule & biologics analytical expertise, method development and complex technical problem-solving skills. A solid history of building teams, processes and Continuous Improvement. Building productive relationships with suppliers, CMO’s, CTO’s, employees and management from diverse scientific backgrounds. Establishing effective, robust Supplier Quality Management processes and building raw material programs from ground up. 6-Sigma Green-Belt with LEAN and 5S expertise.
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Langhorne, Pennsylvania, United States
Sr. Director, Quality AssuranceResponsible for leading and developing the Savara Quality Assurance program, supporting all GCP, and GMP processes while developing a PAI strategy. Key Achievements: Established a robust QMS at our primary CDMO. Developed and completed program specific audit plan for Phase 3 clinical studies. Established a DS/DP/IP Batch.
Responsible for leading and developing the Annexon Quality Assurance program, supporting all GCP, and GMP processes while developing a PAI strategy. Key Achievements: Established and implemented a Supplier Quality Management Program. Successfully audited all CROs, CSOs, and CTLs in support of Annexon’s seven (7) clinical studies. Developed and completed.
(Includes a FTE role as Sr. Director if Quality @ Relypsa)Provide Quality and Regulatory consulting services, auditing, audit program building, and internal audits to medical device, pharmaceutical, gene therapy and combinatorial products corporations in support of FDA strategies, FDA warning letters, submissions, critical raw material/API/DS/DP Stability.
Manage a global team of highly skilled investigators supporting Analytical Laboratory discrepancies, CAPA’s, OOS/OOT/OOE, analytical HPLC, GC, FTIR, NMR, SEC and KF test methods, Manufacturing Operations, Product Complaints, APQR, In-Process, Stability, Environmental QC, Supplier Quality, Incoming Inspection, Raw Materials and Audits in support of.
Lead critical reagent and test standard implementation teams. Assess and close-out analytical, Manufacturing Operations deviations, environmental QC and raw material data for rhPDGF-BB and rhSOD biologics and support the QA & QC teams as a leader, mentor and technical expert for HPLC, LC/MS, GC/MS, FTIR, UV/Vis, HPSEC, CZE, ELISA, LAL, conductivity and pH.
Manage a global team of highly skilled investigators supporting small molecule product complaint investigations. Reviewed and approved all investigation action plans on non-specific release testing for identifying unknowns using HPLC, LC/MS, GC, GC/MS, HPLC. Conducted GC, HPLC testing using Agilent 6890 GC’s and 1200 HPLC’s. QRB and GEG QA lead. QA lead.
Sacramento, California, United States
Prior to Agilent Technologies, Mr. D’Amico held positions of increasing responsibility as Lab Technician, Chemist, Supervisor (Aerojet), Sr. Chemist, Applications Scientist (J&W Scientific), QE/Clinical QA Group Leader (Guidant Corporation) and Sr. Applications Expert (Eksigent Technologies) in the Folsom, CA area from 1986-2009. Areas of expertise.
Other employees you can reach at savarapharma.com. View company contacts for 59 employees →
Sam Kinch
Colleague at Savara Inc.Chicago, Illinois, United States, United States
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Cristina D'Antonio
Colleague at Savara Inc.Buenos Aires, Buenos Aires Province, Argentina, Argentina
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Laura Weber
Colleague at Savara Inc.Philadelphia, Pennsylvania, United States, United States
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Lars Skriver
Colleague at Savara Inc.Copenhagen, Capital Region Of Denmark, Denmark, Denmark
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Mario Guerrero
Colleague at Savara Inc.Splendora, Texas, United States, United States
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Kinjal K.
Colleague at Savara Inc.United States, United States
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Cathy Collins
Colleague at Savara Inc.Nottingham, Maryland, United States, United States
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Claire Sparks
Colleague at Savara Inc.Argentina, Argentina
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Zach Wylder
Colleague at Savara Inc.Austin, Texas, United States, United States
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David Ramsay
Colleague at Savara Inc.San Diego, California, United States, United States
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Quick answers generated from the profile data available on this page.
Michael D. works for Savara Inc..
Michael D. is listed as Executive Director, Quality Assurance at Savara Inc..
Michael D. is based in Langhorne, Pennsylvania, United States while working with Savara Inc..
Michael D. has worked for Savara Inc., Annexon Biosciences, Mbs, Genentech, and Novartis.
Michael D.'s colleagues at Savara Inc. include Sam Kinch, Cristina D'Antonio, Laura Weber, Lars Skriver, and Mario Guerrero.
You can use AeroLeads to view verified contact signals for Michael D. at Savara Inc., including work email, phone, and LinkedIn data when available.
Michael D. holds Bachelor'S Of Science, Analytical Chemistry from Csu Sacramento.
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