About me

Healthcare Consultant | Berlin | www.m-vm.de
Globally active consultant for consulting services in the development of sterile drugs and medical devices, quality management (GMP and ISO), qualification and validation of equipment and processes, and approval/certification (especially CMC part) in the pharmaceutical and medical device industry.

Projects and successes

• Product Development of new products of solid and sterile semisolid forms
• Development management, validation management and preparation of non-clinical registration documentation for 11/2019 drugs approved in the USA ExEm® foam
• Preparation of technical documentation for several Class IIa and Class III medical devices and management of product certification audits.
• Management and implementation of external audits in D, UK and China
• Revision of the QM handbook and entire high-level QM documentation of a medium-sized pharmaceutical manufacturer for autologous cartilage tissue.
• CAPA / deviation management for companies in the Netherlands and UK.
• Extensive process and cleaning validations at a medium-sized pharmaceutical manufacturer.
• Elemental Impurity Assessment according to ICH Q3D.
• MDR certification of material medical devices of class IIb.
• Activity as PRRC according to Article 15 MDR.

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

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

Quality management

Head of QM / GMP compliance

Professional coordination of QM / GMP compliance

Validation representative

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

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

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

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

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”

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