• Evaluation, identification and designation of outsourcing partners (e.g. "fill&finish” CMO for commercial phase of combination product (pharmaceutical & device), raw material suppliers for chemicals, primary and secondary packaging, labeling, logistics etc.).• Coordinating all activities that are necessary to lead a combination product (injectable) to international markets (US& EU). Coordinating 4 different global sites/partners from early development through commercial launch. Frequent travels to all partners (Taiwan, Italy, USA, Belgium Germany, Sweden). Site audits.• Coordinating regulatory, legal and IP activities (US & EU) required for a successful international development, registration and launch. Inventor of two patents (pending).• Leading the setup of a QMS (quality management system) for IPharma.• Leading project risk assessment required for development and dossier.• Business Development support and participation in partner meetings, including licensing.Reporting directly to “board of directors” consisting of joint-venture owner representatives (SHL Medical and Recipharm).

• Quotations and negotiations with customers (as CDO)• Project Management, responsible for:o Main point of contact for customero Management of complete project team (analytics, formulation, quality, regulatory etc.; 1-8 members)o Project time and resource planningo Initiation of investments if necessaryo Meetings, tele-conferences etc.o Invoicing Project scope:• Small, mid size and big pharma as customers (Japan, Austria, Sweden, etc.)• New drug formulation development and manufacturing for pre-clinical and clinical phases; transfer to commercial phase• Generic drug development from scratch to transfer to CMO site• Dosage forms: parenteral, oral, topical, ophtalmic etc. Milestone:2012-2014: main responsibility for successful generic development of oral suspension drug (“from acorn to oak tree”); OTIF

• Internal protein discovery project (2002 – 2003, analysis & purification)• Pre-clinical protein drug development projects as CDO for big-pharma, mid-size pharma, small-pharma (2004-2007, analysis/quality)• Process transfer for a commercial (released) drug product (2008 –2011, analysis/QC, stability, formulation, regulatory) Main responsibilities as project manager:• Management of analytical team (1-10 members)• Project time and resource planning• Negotiations and face to face meetings with clients (as CDO) or CMOs (as client)• Writing and reviewing of experimental plans, reports and regulatory documents (FDA/EMA file) in cooperation with Operations, Regulatory and CMC Other activities: • Member of “new product evaluation” team evaluating new CDO projects (2006-2007)• Member of “new drug discovery evaluation” team (2008)• Analytical method development and qualification (2001-2003)• Organization of internal educational courses (2002-2007)• Supervision of two “examensarbete” (2005 – 2008)• Speaker at two external conferenceso „Analysdagarna“, Chalmers 2006 o Bioprocess International Paris 2007 Other qualifications:• GMP • Member of patent group• Leadership/management courses (Project management & team leadership)• “Skyddsombud” (2002-2011)

Purification and characterization of proteins from bovine adrenal glands for vaccine research

1 year in total during my PhD studies were spent at Magda Claeys group at (then) UIA in Antwerp. Adrenal glands were gathered at the slaughterhouse and proteins purified.