Mike Cope

Mike Cope Email and Phone Number

Founder and Consultant at Cope Pharma Consultancy @
Mike Cope's Location
Greater Guildford Area, United Kingdom, United Kingdom
Mike Cope's Contact Details

Mike Cope personal email

n/a
About Mike Cope

Analytical Development Manager, Pharmaceuticals (specializing in Inhalation Development)Technical writer for CMC submission documentsManaging and monitoring of external outsoucing partnersAuditing of external outsourcing partnersSpecialties: Pharmaceuticals, lab managing, outsourcing, auditing, technical writing

Mike Cope's Current Company Details
Cope Pharma Consultancy

Cope Pharma Consultancy

Founder and Consultant at Cope Pharma Consultancy
Mike Cope Work Experience Details
  • Cope Pharma Consultancy
    Founder And Consultant
    Cope Pharma Consultancy Jan 2011 - Present
    Technical writing consultant, specializing in CMC documentation for US, EU, Jap and ROW.GMP Auditor for pharmacutical laboratories and excipient manufacturers
  • Boehringer Ingelheim
    Analytical Development Manager
    Boehringer Ingelheim May 1996 - Dec 2010
    -Management of Analytical Development team ( 7 staff)-Coordination of stability testing, method development and validation-Project review meetings with Ingelheim colleagues-Management and monitoring of UK CROs-Auditing of UK CROs-Writing and compilation of CMC reports for regulatory submission (NDAs)-Responsible for revenue and capital budget (900K)-Responsible for appraisals and salary review
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  • Boehringer Ingelheim
    Chemistry Services Manager
    Boehringer Ingelheim Sep 1994 - May 1996
    Manager of the Quality Control laboratoryResponsible for chemical release of manufactured products
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  • Marion Merrell Dow
    Section Leader, Pharmaceutical Analysis
    Marion Merrell Dow Jan 1984 - Jul 1994
    -Supervision of 2/3 staff-Development and validation of analytical methods- Stability testing of finished products, raw material testing, qulaity control of clinical supplies, method transfer to production sites in Europe- Compilation of data for regulatory submission- Quality Controller ( Jan-Sept 1993)
  • Umist
    Postdoctoral Research Assistant
    Umist Oct 1980 - Dec 1983
    Application and development of Inductively Couple Plasmas (ICPs)

Mike Cope Skills

Gmp Capa Chromatography Validation Fda Analytical Chemistry Hplc Chemistry Pharmaceutical Industry Regulatory Submissions Cro Glp Quality Control Technology Transfer Sop Biopharmaceuticals Good Laboratory Practice Corrective And Preventive Action U.s. Food And Drug Administration Standard Operating Procedure High Performance Liquid Chromatography

Mike Cope Education Details

Frequently Asked Questions about Mike Cope

What company does Mike Cope work for?

Mike Cope works for Cope Pharma Consultancy

What is Mike Cope's role at the current company?

Mike Cope's current role is Founder and Consultant at Cope Pharma Consultancy.

What is Mike Cope's email address?

Mike Cope's email address is mi****@****eim.com

What schools did Mike Cope attend?

Mike Cope attended University Of Birmingham.

What skills is Mike Cope known for?

Mike Cope has skills like Gmp, Capa, Chromatography, Validation, Fda, Analytical Chemistry, Hplc, Chemistry, Pharmaceutical Industry, Regulatory Submissions, Cro, Glp.

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