Michael Offel

Michael Offel Email and Phone Number

Regulatory Affairs Manager - Chemicals (CMC) @ Enserv
Langkawi, MY
Michael Offel's Location
Langkawi, Kedah, Malaysia, Malaysia
Michael Offel's Contact Details

Michael Offel personal email

About Michael Offel

• PhD / Doctoral Degree in Synthetic Chemistry• 1998-2006 (8 years): Research and Development (R&D) • Synthetic Chemistry• 2006-2011 (5 years): Quality Control Manager • Analytical Chemistry• 2006-2011 & 2015-2024 (13 years): Chemical Regulatory Affairs Manager• 2015-2016 & 2018-2019 (2 years): Chemical Process Safety Analyst

Michael Offel's Current Company Details
Enserv

Enserv

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Regulatory Affairs Manager - Chemicals (CMC)
Langkawi, MY
Website:
enservglobal.com
Employees:
11
Michael Offel Work Experience Details
  • Enserv
    Regulatory Affairs Manager - Chemicals (Cmc)
    Enserv
    Langkawi, My
  • Enserv
    Regulatory Affairs Manager - Chemicals (Cmc)
    Enserv Jan 2023 - Present
  • Merck Group
    Regulatory Affairs Manager - Chemicals (Cmc)
    Merck Group Nov 2021 - Dec 2022
    Homeoffice
    • Evaluation of chemical manufacturing processes to mitigate the risk of the presence of DNA reactive mutagenic N-nitrosamine impurities in pharmaceutical products to limit the carcinogenic risk.
  • Australian Pesticides And Veterinary Medicines Authority
    Regulatory Affairs Manager - Chemicals (Cmc)
    Australian Pesticides And Veterinary Medicines Authority Jul 2019 - Mar 2021
    Canberra, Australia
    • Safety risk assessments of international submitted applications for the registration of pesticides and veterinary medicines. • Evaluation of manufacture methods of chemicals in regards of synthetic routes and formation of impurities of toxicological concern.
  • Dsm
    Chemical Process Safety Analyst
    Dsm Mar 2018 - Mar 2019
    Aesch, Basel-Country, Switzerland
    • Process safety analysis of industrial operating procedures and consequences of hazardous chemical releases.
  • Enserv
    Regulatory Affairs Manager - Chemicals (Cmc)
    Enserv Jun 2015 - Mar 2018
    Hong Kong
    • Evaluation of country-specific chemical regulations and risk assessment for the export of chemicals and products. Preparation and submission of product dossiers (European REACH Product Safety legislation).• 2015: Chemical Process Risk Analyst at Samsung Electronics, South Korea in cooperation with TÜV Hessen, Germany (certification company). Process safety management of highly hazardous chemicals.
  • Riotinto
    Process Chemist
    Riotinto Oct 2011 - Mar 2015
    Port Hedland, Australia
    • Responsibility for chemical quality control laboratory and occupational safety (EHS).
  • Dexa Medica (Member Of Dexa Group)
    Head Of Quality Control Laboratory
    Dexa Medica (Member Of Dexa Group) Apr 2009 - Mar 2011
    Greater Jakarta Area, Indonesia
    • Responsibility for quality control laboratory. Method Development and Validation of Analytical Procedures (Liquid Chromatography-Mass Spectrometry. Performance of chemical stability studies.
  • Tüv Rheinland Ag
    Head Of Quality Control Laboratory & Regulatory Affairs (Chemicals)
    Tüv Rheinland Ag Apr 2006 - Mar 2009
    Shenzhen, Guangdong, China
    • Supervisory responsibility for quality control laboratory (12 employees). • Method Development and Validation of Analytical Procedures for determination of contents of pesticides, persistent organic pollutants, volatile organic compounds, polycyclic aromatic hydrocarbons and heavy metals in products. • Preparation and submissions of product dossiers (REACH Product Safety Legislative).
  • Merlion Pharmaceuticals Pte Ltd
    Senior Research Chemist
    Merlion Pharmaceuticals Pte Ltd Apr 2005 - Mar 2006
    Singapore
    • Organic synthesis and structural elucidation (Nuclear Magnetic Resonance spectroscopy) of new chemical entitles (NCE's) to target multidrug-resistant bacterial infections.
  • Monash University
    Postdoctoral Research Chemist
    Monash University Nov 2001 - Oct 2004
    Melbourne, Australia
    • Organic synthesis and structural elucidation (Nuclear Magnetic Resonance spectroscopy) of new chemical entitles (NCE's) to target viral infections.

Michael Offel Skills

Pharmaceutical Industry Organic Chemistry Process Safety Life Sciences Mining Risk Assessment Customer Service Quality Control Cmc Regulatory Affairs Research And Development Process Optimization Iso Standards Drug Development Neuroscience Quality Assurance Chemistry Regulatory Affairs Liquid Chromatography Mass Spectrometry Inspection Good Laboratory Practice Auditing Intellectual Property Standard Operating Procedure Spectroscopy Microsoft Office Cross Functional Team Leadership Management German English Fda Gmp New Drug Application Viral Hepatitis Analytical Method Validation Hse Auditing Process Auditing Biocides Clinical Chemistry Gxp Non Conforming Synthetic Organic Chemistry Nmr Spectroscopy Structure Elucidation Hseq Mass Spectrometry Product Safety Atex Jsa Good Manufacturing Practice Nuclear Magnetic Resonance Engineering Project Planning Process Engineering Project Management Gas Chemical Engineering Manufacturing Laboratory Skills

Michael Offel Education Details

Frequently Asked Questions about Michael Offel

What company does Michael Offel work for?

Michael Offel works for Enserv

What is Michael Offel's role at the current company?

Michael Offel's current role is Regulatory Affairs Manager - Chemicals (CMC).

What is Michael Offel's email address?

Michael Offel's email address is mi****@****ook.com

What schools did Michael Offel attend?

Michael Offel attended Aston University.

What are some of Michael Offel's interests?

Michael Offel has interest in Science And Technology, Education.

What skills is Michael Offel known for?

Michael Offel has skills like Pharmaceutical Industry, Organic Chemistry, Process Safety, Life Sciences, Mining, Risk Assessment, Customer Service, Quality Control, Cmc Regulatory Affairs, Research And Development, Process Optimization, Iso Standards.

Who are Michael Offel's colleagues?

Michael Offel's colleagues are Edson Camargo, Balijepally Venkata Narasimha Rao, Walter Arenas, Arvind Goud, Asif Khan, Pourichaya Pindontri.

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