Michael Arent Email & Phone Number

Durham, North Carolina, Us

Cambridge, Cambridgeshire, Gb

- Lead drug product characterization studies to support regulatory submissions, design changes to devices (21 CFR Part 820) and formulation optimization.- Lead investigations in pMDI container closure systems working with internal (analytical, mfg, clinical packaging, commercial manufacturing and QA) and external (vendors) on root cause, CAPAs, FMEA and risk mitigation.-Design the necessary experiments for drug product / container closure development through phase appropriate product characterization for regulatory filings. Track, trend and summarize data to senior management and CMC teams (Bevespi pMDI, Breztri pMDI, AirSupra pMDI).. -Proficient in the use of non-destructive analytical techniques such as computed tomography (micro CT) and scanning electron microscopy (eSEM) in identifying the root cause to atypical observations.-Experience in authoring sections of European regulatory submissions (MAA) , INDs, NDAs, DMFs and investigative brochures (IBs) for pMDI drug products, leading to the successful approval of AirSupra pMDI.

Somerset, Nj, Us

Manage customer deliverables through the various stages of planning, resourcing, executing, supervising and reporting/trending of data in a LEAN environment using customer milestones and division performance standards. Supervise technical staff to include work assignments and development management. Direct activities of customer commitments for formulation/product development of nasal sprays and dry powder inhalers, method transfers, clinical trial release and analytical support. Simultaneous management of multiple projects (external customers), maintaining responsibility for project outcome, on-time delivery (OTD) and customer interaction/visits. Provide guidance to customers on quality attributes such as formulation, packaging and specifications to ensure their product is as successful as possible.

Rahway, New Jersey, Us

Analytical chemist within the Respiratory Product Development group with experience developing and validating analytical methods for emulsions, nasal spray, MDI and DPI dosage forms from pre-phase I through phase III. Successfully led a team of scientists through the development of a number of dry powder and nasal suspension projects through Phase II.

Rahway, New Jersey, Us

Execute analytical release and stability testing of commercial drug products with emphasis on metered dose inhalers (Proventil, Vanceril, Vancenase and Vancenase Pockethaler) as well as dry powder inhalers (Asmanex) and nasal sprays (Nasonex). Additional testing conducted on other commercial liquids, creams and ointments.

Rahway, New Jersey, Us

Commercial manufacturing of Proventil and beclomethasone metered dose inhalers

M.S., Chemistry

B.S, Biochemistry