Michael D. Email & Phone Number

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 Record Release process and successfully integrated QPs for EU Skills: High-Performance Liquid Chromatography… Show more 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 Record Release process and successfully integrated QPs for EU Skills: High-Performance Liquid Chromatography (HPLC) · Corrective and Preventive Action (CAPA) · Good Clinical Practice (GCP) · Quality Auditing · Quality Management · Auditing · Good Manufacturing Practice (GMP) · Good Laboratory Practice (GLP) · Business Development · Quality Assurance, CAPA, Complaints, Investigations, Deviations, OOS/OOT/OOE, Change Control, Document Management. Show less

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 program specific audit plans for the top three (3) Annexon Phase 2/3 clinical studies. Established a DS/DP/IP Batch… Show more 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 program specific audit plans for the top three (3) Annexon Phase 2/3 clinical studies. Established a DS/DP/IP Batch Record Release process and successfully integrated QPs for EU IP. Show less

(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, training, QS development / implementation and transfers to CMOs, CTLs and CSPs. Provide bench chemistry support, HPLC, GC, HPLC-MS… Show more (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, training, QS development / implementation and transfers to CMOs, CTLs and CSPs. Provide bench chemistry support, HPLC, GC, HPLC-MS, FTIR and GPC equipment installation and qualification. Provide support of environmental monitoring in manufacture and aseptic areas. Train other chemists on analytical techniques, technical report writing and Design of Experiments. Lead FDA audit preparation and support regulatory inspections and strategies.Key Achievements: Provide HPLC method review and requalification for new drug products. Key team contributor to a successful Pre-Approval Inspection (PAI) Quality & Regulatory key contributor of revised NDA. Established and trained company on Product Complaint / AE program. Established Batch Record Release qualification and monitoring program. Show less

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 Biopharmaceuticals and combination devices. Reviewed and approved all investigation action plans on non-specific release testing for identifying… Show more 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 Biopharmaceuticals and combination devices. Reviewed and approved all investigation action plans on non-specific release testing for identifying unknowns. SME for QRB and MRB sub-teamsKey Achievements: Developed analytical training modules (Proteins and Small Molecules) for qualifications used by investigators. Developed, implemented and led Senior level “Technical and Compliance team” supporting Direct Materials to proactively identify cross-site risks to the material release process. Developed a risk-based approach for Manufacturing Operations to assess lot release criteria. Show less

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, investigations, risk assessments and technological improvements. Key contributor to (9) technical process improvement processes using… Show more 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, investigations, risk assessments and technological improvements. Key contributor to (9) technical process improvement processes using LEAN, 5S and 6-Sigma methodologies (leader of 3), CMC Regulatory. Assist with GCP materials and training. QA/QC/MS&T/Manufacturing CAPA lead investigator and approver. Coach and co-author laboratory investigations. Author and/or approve analytical, environmental and in-process testing SOPs.Key Achievements: Developed a set of eleven (11) analytical training modules used to standardize and build knowledge of many analytical techniques. The training provided a foundation for scientists of all levels to function consistently, enhance technical writing skills and build core competencies. Provide hands-on instrument training to QC. Awarded the “V3” site award for developing & implementing a right first time (RFT) error reduction process. Developed and implemented “Analytical Method Capability & Sustainability” process for analytical method lifecycle management. Show less

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 for all Genentech biologics, Roche small molecule and supplier manufacturing operations deviations. Key Achievements: QA Team for… Show more 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 for all Genentech biologics, Roche small molecule and supplier manufacturing operations deviations. Key Achievements: QA Team for seven (7) class II/III product recalls and one Market Withdrawal; key contributor to the global recall process revisions. Successfully developed and transferred analytical methods to contract testing sites in support of product investigations; testing included HPLC, GC/MS, FTIR, TLC, Dissolution, friability. Hired and trained a team of Technical Managers and Sr. Technical Managers to investigate product complaints and potential counterfeits. Developed product knowledge qualifications used by investigators for training. Successfully led an FDA inspection focused on product complaints and pharmacovigilance (PV) with no 483’s issued. Show less

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 included, protein/peptide analysis, small molecule chemistry and analysis, 2D-HPLC, FTIR, CE, GC, GC/MS, LC, LC/MS and nano-HPLC, Quality… Show more 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 included, protein/peptide analysis, small molecule chemistry and analysis, 2D-HPLC, FTIR, CE, GC, GC/MS, LC, LC/MS and nano-HPLC, Quality Assurance, Quality Control and R&D method development. Show less

Bachelor'S Of Science, Analytical Chemistry

Master Of Business Administration - Mba, Technology Management