Dr. Andreas B. Meier

Dr. Andreas B. Meier

AT A GLANCE

  • More than 20 years’ experience in quality management and the development of sterile pharmaceuticals

  • Auditor with extensive experience in preparation and support of internal and performance of external audits

  • Profound knowledge of European and international GMP regulations as well as ISO standards

  • Experienced manager with pronounced team skills and a high level of motivation and assertiveness

  • Strategically orientated with an excellent grasp of business-related aspects

PROFESSIONAL EXPERIENCE

04/2013 – 12/2018

Farco-Pharma GmbH | Cologne, Germany | www.farco-pharma.de
Global provider of products for urology and outpatient medical care
Turnover of €30 million | 30 employees

Head of R&D and quality management
Responsibility: budget up to €2 million | Managerial responsibility for 6 members of staff

  • Development of new products
  • Continuous improvement of the existing product portfolio as well as existing
    production processes
  • Qualification of alternative suppliers for existing and new products, components, forms of packaging, etc.
  • Professional management of the development processes as well as transfer of new products to series production
  • Provision of non-clinical approval documents (CMC section)
  • Management and performance of internal and external audits
  • Maintenance of the QM manual and the entire documentation of the QM system
  • CAPA / deviation management
  • Responsible support for audits performed by national and international authorities, notified bodies and customers
  • Introduction of corrective measures to rectify weaknesses
  • Head of vigilance / pharmacovigilance
  • Safety officer for medical products
  • Release / rejection of medical products as the «person responsible for regulatory compliance»

Successes:

  • Successful new development of own products such as InstillaGel Hydro®, Farco-fill Protect® or Instillamed®
  • Successful development of new toll-manufactured products such as Jelido® in
    Canada and ExEm® in the USA including the creation of the CMC approval
    documents
  • Development of a globally patented sterilisation process and thus avoidance of
    20% of process-related off-specification batches
  • Successful support of five master’s degree students and one PhD student
  • Invention of products, processes and recipes and corresponding patent applications

05/1996 – 03/2013

Klosterfrau Berlin GmbH | Berlin, Germany | www.klosterfrauberlin.de
Company in the self-medication market active throughout Europe | 3 employees

Quality management

Since 01/12

Head of QM / GMP compliance

Since 03/08

Professional coordination of QM / GMP compliance

Since 07/00

Validation representative

Since 07/98

Quality management representative (QMB) pursuant to ISO 9001 and 13485

  • Recipe development, stability testing, optimisation of production parameters
  • Development and validation of analytical processes
  • Project management of FDA approval

Successes:

  • Preparation, execution and successful implementation of a pre-approval inspection by the FDA within three years
  • Successful development of toll manufacturing for Suprasorb G, Dianatal and Prefert
  • Product development of pre-filled sterile single-use syringes including recipe optimisation
  • Set-up and development of a quality management -systems for Klosterfrau Berlin GmbH
  • Achieved recipe stabilisation of the main product Instillagel® after analytical clarification of causes and thus created the prerequisite for cost-effective manufacturing
  • Optimisation of the analytic process, thus achieving savings up to 2017 of €1.2 million

09/1994 – 06/1995

Co-author with Prof. Dr. J. Mulzer of “Chiral Auxiliaries in Organic Synthesis”

01/1989 – 11/1994

Free University of Berlin | Berlin, Germany | www.fu-berlin.de

  • Research associate and assistant in the chemistry course for medical students
  • Tutor in the chemistry course for medical students

03/1985 – 05/1989

Meinungsforschungsinstitut Marplan (a polling institute) | Offenbach, Germany | www.marplan.de
Freelancer

EDUCATION

10/1982 – 09/1994

Free University of Berlin | Berlin, Germany | Studies of chemistry    

  • Thesis under the supervision of Prof. Dr. H. Kurreck (08/88 – 07/89)
    “Synthesis of vitamin B2 derivatives and ESR/ENDOR investigation of the anion radicals in inverse micelles”
  • PhD under the supervision of Prof. Dr. J. Mulzer (12/89 – 09/94)
    „Synthesis of homochiral proline derivatives as building blocks for peptidomimetics”

1975 – 1981

Abitur (university entrance level exams) at the Hans-Carossa-Gymnasium (secondary school) | Berlin, Germany

PUBLICATIONS

  • Synthesis of Enantiopure 1,2-Didehydropyrrolidine, D-Proline, and Oxazoline De-rivatives via Staudinger-Aza-Wittig Cyclisation of γ-Azido Aldehydes:
    (J. Mulzer, A. Meier, Synthesis 1996, 123–132)
  • Synthesis of Cis- and Trans-3-Hydroxy-D-Proline and (+)-Detoxinine:
    (J. Mulzer, A. Meier, J. Org. Chem. 1996, 61, 566-572)
  • Steam Sterilization of Pre-Filled and Blistered Ready-to-Use Syringes:
    (A. Meier, V. Meßmer, Pharmind 2006, 11, 1318–1319)
  • Steam Package – Terminal Steam Sterilization of Pre-Filled and Blistered Syringes in their Final Package, The Universe of Syringes & Injection Devices
    (23–25 October 2006, Bethesda, MD: A. Meier, H. Miething)