About me

Achim Schaeffler

Summary

  • Experienced Research & Development / Regulatory / Manufacturing Executive in the Life Sciences Industry
  • Experience includes New Chemical /Biological Entities and Life Cycle Management in Big-Pharma and Biotech
  • Consultant Pharma R&D;
    Quality, Chemical & Pharmaceutical Development, Quality Assurance;
    related activities in Drug Regulatory Affairs/ Clinical Dev/ Intellectual properties
  • Pharmacist / Qualified Person

 

 

 

 

 

 

 

 

 

 

 

Industrial Career

More than 25 years in Big-Pharma and Biotech Industry at

Schaeffler Pharma Consulting (2011 – today) 

Owner

Horizon Pharma INC, Deerfield, IL, USA; Mannheim, D  (2010 –2011)

Executive Vice President Technical Development & Manufacturing, Managing Director Horizon Pharma GmbH

Main activities/ responsibilities at Horizon

  • Member of the Executive Management of Horizon Pharma Inc
  • Key role in the integration process of Nitec Pharma and Horizon Therapeutics to Horizon Pharma
  • Responsible for CMC activities /technical development of all Horizon projects and manufacture of all Horizon products
  • Supply Chain Management through reliable external partners
  • Actively involved in Duexis and Lodotra/Rayos NDA filings. US approvals received in 03/2011 and 07/2012
  • Develop and execute together with License partner filing strategy for regulatory approvals in Asia Pacific and Latin America
  • Support Horizon Pharma INC during the IPO in July 2011(NASADQ HZNP)
  • Fulfill obligations as Managing Director of German GmbH

Nitec Pharma, Reinach CH, Mannheim D (2004-2010)

Co-founder, Executive Vice President R&D/ Manufacturing / Intellectual Properties
Member of the Board of Directors of Nitec Pharma AG; General Manager

Main activities/ responsibilities at Nitec

  • Foundation of Nitec Pharma / Merck KGaA Spin-off in 07/2004
  • Rounds of financing in 2004, 2007 and 2008 with a total raise of about m70 US$
  • Building up infrastructure of the newly founded company Nitec Pharma
  • Clinical Research and Development: Expertise in Rheumatoid Arthritis, Severe Asthma, Osteoarthritis, Neuropathic Pain
  • Several publications in clinical journals (2008: The Lancet) and poster presentation at EULAR and ACR congresses
  • Technical Development/ Production of modified release and standard tablets
  • Supply Chain Management through reliable external partners
  • Development and implementation of a Quality System for Pharmacovigilance and Final Product/ EU Market Release
  • Successfully passed several inspections by authorities and partners
  • In-licensing activities
  • Regulatory approvals: Lodotra®: EU Approval 12/2008
  • EU Regulatory Scientific Advises (D, SE, UK)
  • US FDA activities: pre IND meeting, EOP2 meetings, pre NDA meeting
  • Management of IP portfolio worldwide through EU and US patent law firms
  • Support to merge Nitec Pharma with Horizon Therapeutics (03/2010)

Merck KGaA (1991-2004)

Several positions: from Pharmaceutical/ formulation Scientist up to Head of Global Pharmaceutical Development

Main activities/ responsibilities at Merck KGaA

  • Global development activities managed through centers in UK, France, Germany
  • Development of dosage forms with focus on solid orals, novel Drug Delivery Systems, injectables
  • Development /validation of analytical methods, stability testing according to ICH
  • Manufacturing, packaging, labeling, distribution of clinical trial material for worldwide clinical trials
  • Scale up activities / transfer of projects to several manufacturing sites
  • Dossier preparation (Quality part): IND, IMPD,  eCTD, NDA
  • FDA Pre-Approval Inspections
  • Deputy head of commercial manufacturing
  • Qualified Person according German Drug Law (AMG §15)
  • Member of US based strategic Therapeutic Area Team „Oncology“ responsible for quality including commercial manufacture
  • Project Champion of priority projects (EGFR – MAB)
  • Due diligence of external projects to be in-licensed

Schwarz Pharma (1991) – Now UCB Group  – Formulation Research Fellow

Boehringer Ingelheim (1988-1990) – PhD in Pharmaceutical Technology/ Drug Delivery

Education

Pharmacist with PhD in Pharmaceutical Development / Drug Delivery Systems

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