James Brain

James Brain Email and Phone Number

Associate Director Regulatory Affairs CMC @ GE HealthCare
Rickmansworth, GB
James Brain's Location
Rickmansworth, England, United Kingdom, United Kingdom
James Brain's Contact Details

James Brain work email

James Brain personal email

n/a
About James Brain

A highly skilled technical leader with over 30 years experience within the pharmaceutical industry supporting manufacturing supply chain and new product introductions.Extensive knowledge and experience of process and analytical chemistry covering active pharmaceutical ingredients, intermediates and a diverse range of pharmaceutical dosage forms with specialities in solid dose oral, inhalation, parenteral and PET / SPECT radiopharmaceutical products.Significant experience in the development and validation of chemical and microbiological methods, physiochemical characterisation (supporting pre-formulation studies), stability testing, technology transfer, extractables / leachables studies, problem solving and design of experiments.Sound understanding of regulatory requirements with significant CMC experience supporting global regulatory submissions. Extensive experience of regulatory audits (FDA, MHRA).Current position provides technical support leadership supporting new product introduction, market expansion and continuous process improvement within a business characterised by high global service reliability, short delivery times and complex manufacturing plant.I am a Member of the Royal Society of Chemistry and Chartered Chemist, and a technical advisor for the British Pharmacopoeia Commission on the panel of experts for Radioactive Materials (RAD).

James Brain's Current Company Details
GE HealthCare

Ge Healthcare

View
Associate Director Regulatory Affairs CMC
Rickmansworth, GB
Website:
gehealthcare.com
Employees:
57831
James Brain Work Experience Details
  • Ge Healthcare
    Associate Director Regulatory Affairs Cmc
    Ge Healthcare
    Rickmansworth, Gb
  • Ge Healthcare
    Senior Technical Manager
    Ge Healthcare Jan 2017 - Present
    Chicago, Us
  • Ge Healthcare
    Operations Quality & Technical Support Leader
    Ge Healthcare Apr 2014 - Dec 2016
    Chicago, Us
  • Ge Healthcare
    Operations Technical Support Leader
    Ge Healthcare Apr 2013 - Mar 2014
    Chicago, Us
  • Ge Healthcare
    Analytical Development Manager
    Ge Healthcare Oct 2000 - Apr 2013
    Chicago, Us
  • Amersham
    Analytical Development Manager
    Amersham 2000 - 2004
  • British Biotech
    Pre-Formulation / Formulation Scientist
    British Biotech Jan 2000 - Oct 2000
  • British Biotech
    Team Leader, Analytical Sciences
    British Biotech Jul 1997 - Jan 2000
  • Merck-Lipha Pharmaceuticals
    Development Chemist
    Merck-Lipha Pharmaceuticals Apr 1991 - Jul 1997
  • The Wallis Laboratory
    Senior Analytical Chemist
    The Wallis Laboratory Nov 1989 - Mar 1991

James Brain Skills

Medical Diagnostics Chromatography Tlc Radiochemistry Gas Chromatography Particle Size Analysis Chemistry Hplc Cgmp Gmp Gxp Biotechnology Change Control Inhalation Regulatory Affairs Validation Trackwise Method Development Purification Regulatory Requirements Drug Discovery Quality System Analytical Chemistry V&v Pharmaceuticals Dissolution Testing Pharmaceutics Drug Development Mass Spectrometry Lc Ms Stability Testing Microbiology Regulatory Submissions Formulation Project Management Pharmaceutical Industry Problem Solving Technology Transfer Glp Lims Uv/vis Capa Statistics R&d Fda Sop 21 Cfr Part 11 Ion Chromatography Biopharmaceuticals

James Brain Education Details

  • Queen Mary University Of London
    Queen Mary University Of London
    Chemistry
  • The Open University
    The Open University
    Senior Management

Frequently Asked Questions about James Brain

What company does James Brain work for?

James Brain works for Ge Healthcare

What is James Brain's role at the current company?

James Brain's current role is Associate Director Regulatory Affairs CMC.

What is James Brain's email address?

James Brain's email address is ji****@****ail.com

What schools did James Brain attend?

James Brain attended Queen Mary University Of London, The Open University.

What skills is James Brain known for?

James Brain has skills like Medical Diagnostics, Chromatography, Tlc, Radiochemistry, Gas Chromatography, Particle Size Analysis, Chemistry, Hplc, Cgmp, Gmp, Gxp, Biotechnology.

Who are James Brain's colleagues?

James Brain's colleagues are Angel Him, Alexandra Kartashova, Stephen Di Salvo, Raffaella Dibenedetto, Katherine Young, Fabio Berti, Kenneth Kump.

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