Consultant Product & Process Management Chemical & Pharmaceutical Industries

Core Competencies
Broad and profound hands-on experience in the complete range of pharmaceutical & chemical process management, from early R&D to large scale manufacturing of building blocks, intermediates, APIs, drug product, advanced materials.

• Analytische Chemie
• Chemische Verfahrenstechnik1 J.
• Fertigungsoptimierung
• Fertigungstechnik (allg.)
• Grundlagenforschung
• Management (allg.)
• Manufacturing Resources Planning
• Prozessoptimierung
• Qualitätsdokumentation
• Sicherheitsmanagement

Leader in process chemistry and CMC, RA and QA, including: MBR-review, data integrity control, Deviation-, CAPA, Change Control with Risk assessments and final APQR compilation with continuous oversight from R&D to scale-up and routine large scale GMP-manufacturing.
Critical author and reviewer of scientific and business documents, enabling smart API- and DP- regulatory authorization, with support of best CMO-selection, technical transfer to large scale production, best practice in sampling and QC, with continuous process efficiency control and process optimization during large scale cGMP-manufacturing campaigns.

Effective manager and consultant in process & project management with international business partners in very complex and extremely challenging technology innovations, process transfer and improvement.
Engaged leader and motivator, improving cooperation between inhouse departments and international partners, to improve overall efficiency, quality and safety of critical operational processes.

QA-Management: APQR compilation & review

CMC-Consulting in Process Development & Manufacturing

Material management in Chemical Production

Consulting for Optimization in Process Chemistry

Business consulting Due diligence

Process risk analysis / Process Optimization / Process Development / Chemical Manufacturing at CDMOs.

Integrated Process RD & Scale-up

Large Scale Manufacturing