Michael Mcnaught Email & Phone Number

Ingelheim Am Rhein, Rhineland-Palatinate, De

-Support the Drug Formulation Analysis group by independently designing and performingRT-qPCR molecular assays to measure viral titers of Advanced therapy medicinal products(ATMPs) in a GLP environment- Developt, qualify, and validate new HPLC analytical chromatography methods-Report and treat data with a high level of integrity and ethics-Present results responsibly at team meetings-Work in a collaborative manner with members of other departments-Review, approve, write, and revise Standard Operating Procedures (SOPs) and Technical ReportsEffectively communicated and defended own work in the context of team and department goals both orally and in writing-Provide guidance and expertise to advance specific projects or evaluate and propose newtechnologies and concepts in support of multiple projects-Comply with applicable regulation, perform all work in a safe manner and maintain properrecords in accordance with SOPs and policies

Stamford, Connecticut, Us

-Supported the Pre-PCR group by performing manual extraction of DNA from blood, saliva,semen, cultured cells and amniotic fluid-Functioned as the Subject Matter Expert (SME) for the manual extraction group whilesupervising and training new group members-Used various automated and no-automated laboratory instruments (ex: Janus, Promega Maxwell RSC, Traxcer, Scinomix, etc) for the extraction, transferring and storage of DNA-Used LIMS (ex: Labcollector and Medgist) to track and store extracted DNA samples as well as the concentration of samples and other relevant patient information-Performed validation of QC hold kits before in-process use-Executed all laboratory task as per SOPs and CLIA regulatory guidelines

-Supported the Analytical Commercialization Technology group by assisting with thedevelopment of analytical testing methods-Performed CMC and Stability studies on small molecules. Data and reports from studies used in INDA and NDA regulatory submission filings-Performed HPLC/UPLC, GC, KF Titration, dissolution, water activity, hardness, and fineness of dispersion analysis on small molecule-Performed all tasks in a safe manner and in accordance with SOPs, GxP and other regulatoryguidelines-Maintained proper record of each experiment

-Supported the Process Analytics group by performing protein purification (Drip Column/ Teacan) and chromatography analysis (HPLC/UPLC) on large molecules-Managed the storage and retrieval of retained samples and reference standards-Performed all tasks in a safe manner and in accordance with SOPs, GxP and other regulatoryguidelines-Maintained proper record of each experiment

Basel, Baselstadt, Ch

-Performed QC testing of raw materials, in-process and finished CAR-T samples using methods such as HPLC, osmolarity, UV/VIS, refractometer, and viscometer-Reviewed /approved data generated by other team members -Performed qualification/optimization of methods as per appropriate protocols-Contributed to OOS/OOE/OOT investigations and deviation investigations -Worked with LabWare LIMS and/or other QC data systems -Maintained GMP/GLP quality systems and follows quality policies

Master Of Science - Ms, Molecular Biology

Bachelor Of Science - Bs, Biochemistry