Jeff Michaud

Background

About Jeff Michaud

Scientific Leader with 25 years pharmaceutical experience in Quality Control, Research & Development, Product Development and Stability; including 8 years in supervision role and 2 years in management role including laboratory remediation. Implementation of new laboratory equipment and personnel meeting deliverables and applying training, coaching and motivation for my direct reports to achieve department goals during the product life cycle management of several solid dose and liquid dose finished products. Strengths include building relationships with and supporting the needs of internal departments (i.e. Technical Operations, Formulation Development, Quality Control, Method Development, Validation, Stability and Production) as well expertise in capital expense purchases for laboratory equipment, validation of laboratory software and equipment, creating technical protocols and reports, developing and validating laboratory test methods, Stability trending with regression analysis to support shelf life and responding to regulatory agencies deficiency letters during a product submission. Team player with polished communication skills: verbal, written, interpersonal, presentations, and rapport building. Proven leader in increasing productivity, reducing costs, budgeting equipment purchases and service contracts, laboratory remediation and motivating/ training staff. AREAS OF EXPERTISE-FDA and Health Canada Regulatory Submission requirements -Purchasing Laboratory Equipment, Validating and Operational Training -Bioavailability and Bioequivalence Testing of Nasal Sprays -Laboratory Leadership through DDMI Leadership Development -Department Compliance Coordinator with Health & Safety -Test Method Development and Validation -Protocol, SOP and Technical Report Writing -Test Method Transfer -Project Management -Stability Program, Trending and Shelf Life Assessment of NHP and OTC solid dose products