Experience

Trias Pharma GmbH

• Switzerland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Pharmaceutical consultant

  • Mar 2020 - Present

  Providing technical guidance, R&D and CMC management during the drug product development processes from early stage to commercial launch. Providing technical guidance, R&D and CMC management during the drug product development processes from early stage to commercial launch.



Consultys CH

• Switzerland
• Business Consulting and Services
• 1 - 100 Employee

• Senior Pharmaceutical consultant

  • Sep 2019 - Jan 2020

  Senior consultant Aston Life Sciences providing consulting services in Pharmaceutical and consumer healthcare industries

• Senior Pharmaceutical consultant (Novartis Parma AG)

  • Jul 2017 - Aug 2019

  Senior consultant providing services to Novartis Pharma AG for drug product formulation development late phase (Drug Product Project Leader oncology). Succesful collaboration with project team based in Singapore, India,US,Europe.



Real Staffing

• United Kingdom
• Staffing and Recruiting
• 500 - 600 Employee

• Senior Consultant external manufacturing & product supply strategy

  • Jun 2017 - Jun 2017

  Consultant providing services to Bayer Consumer Care AG Consultant providing services to Bayer Consumer Care AG



Aenova Group

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Corporate Manager R&D project evaluation & coordination

  • Apr 2013 - May 2017

  Present CDMO capability to customers and provide technical expertise to evaluate new RFQ, RFI.Identify Aenova sites for development activities and commercial production for solid dosage forms: Rx, Gx, OTC, dietary supplement.Elaborate detailed pharmaceutical development proposals/strategies and define corresponding budget. Act as R&D sales manager to present quotations/timelines to customers.Define and communicate assumptions to sales directors for elaboration of commercial offers.Coordinate work across different R&D locations to manage development projects for pharmaceutical solid dosage forms within the Aenova Group and lead the implementation of new technologies/dosage forms (e.g. freeze drying/ODT).Ensure project management and give support to project leaders, e.g. acting as pharmaceutical process engineer, CMC team member, PAI team member.Execute capacity calculations for R&D projects and for the annual budgeting process.

• R&D Project Manager - Solid dosage forms -

  • Feb 2012 - Mar 2013

  Manage drug product formulation development for customers in pharmaceutical and healthcare industries e.g.complex and succesful colaboration with international customer project team based in EU, US and JP



Skyepharma

• France
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Technical Team Leader CMC

  • Jan 2007 - Jan 2012

  Manage and lead multi-functional/multi-cultural technical project teams and ensure the pharmaceutical development coordination from early development to commercial launch.Contribute to and control reports for regulatory purposes to support elaboration of IMPD,IND, Module 3 of the dossier, NDA, ANDA and MAA.Ensure state of the art formulation and process development work of modified release dosage formsDefine, control and approve technical resources via ERP (Navision software).Collaborate closely with business development unit for elaboration of development offer, confidentiality agreement, and development agreement and participate in due diligence activities.

• Head of Laboratory (Pilot Plant)

  • Jan 2001 - Dec 2006

  Define, organise, control and supervise cGMP production and development project activities.Implement new development and clinical supplies services such as topical dosage forms, DPI technology (capsules for inhalation), solubilisation technology (high pressure homogeniser), medicated chewing gum within the cGMP pilot plant.Write relevant formulation and process development reports and implement Quality by Design approach for process development in accordance with ICH Q8/Q9/Q10 Guidelines.Manage the manufacture of marketed solid dosage forms for the Swiss market, control the annual product review report and represent the clinical supply/production group during quality audits e.g. Swiss Medic audits, customer’s audits and pre-approval inspection.Organise and supervise the transfer of formulation and processes to Skyepharma production site and customer sites. Provide production sites with technical expertise for the process validation strategy and the elaboration of process validation protocols and reports.Represent Formulation and Process development solid dosage forms expertise in join project teams with clients.

• Group leader

  • Jan 1998 - Dec 2000

  Supervise a team of 4 technicians and define appropriate GMP documentation, batch records, SOP’s, IQ, OQ, PQ, protocols to maintain the appropriate GMP level in the solid dosage form department.Ensure internal training of production team and external training at customer’s production site.Fix trouble shooting in commercial production sites.Provide engineering and technical support for the development of new equipment e.g. elaboration ofURS for Multilayer tablet press and press-coating tablet press.Coordinate the installation and qualification of new industrial equipment in the manufacturing site e.g. high shear mixer, fluid bed dryer, multilayer tablet press, press coating tablet press.



Jago pharma AG

• Switzerland

• Scientist

  • Apr 1995 - Dec 1997

  Contribute to set up a new cGMP pilot plant for process development and clinical supplies. Execute the manufacture of clinical batch at pilot scale (Geomatrix tablets™) and participate in scale-Up and transfer of drug product from development site to customer production sites in Europe and US. Characterize solid dosage forms with powder compaction simulator e.g. for optimization of drug product compositions and improvement of physical characteristics of the finished product. Expert in pharmaceutical technologies including high shear mixer, low shear mixer, fluid bed dryer, roller compactor, milling equipment, blender, multilayer tablet press, perforated coating pan, capsule filler.