Michael Ennis Email & Phone Number

Belfast, Gb

Newry, Northern Ireland, United Kingdom

Experienced in supporting simultaneous multiple new product development, submission and launch programmes on time (including working with CROs) and contributing to various aspects of compliance and remediation projects..Providing expert advice for analytical aspects across multifunctional teams within the company and to CROs.Major contributor to responses to pre-approval and post-approval queries received from Regulatory Authorities.Working closely with and advising SMEs of pre-approval functions including Formulation Development, Reverse Engineering, Pre-approval Process Validations, Pre-approval Stability and Quality Control and Quality Assurance. Actively participating in Technology Transfers, manufacturing scale up, setting up specifications, process validation and stability studies.Working closely with and advising QA on technical and relevant quality aspects of new and existing products.Contributing to the analytical method development and validation strategies for new and existing products. Providing input in various risk assessments and in setting of timelines.

County Cork, Ireland

Team leader over six analysts in QC chemistry testing laboratory

research in milk protein as food ingredient, in collaboration with major food ingredients producer.

PGCE training and teacher of Chemistry and Science

research in protein chemistry in Alzheimer's disease

research in peptidergic neurotransmission

Doctor Of Philosophy - Phd, Biochemistry, Phd In Protein Purification.

B.Sc., Biochemistry, 2:1 Hons.