Doug Neumann

About Doug,

Doug has over twenty years of senior project management/engineering experience in 1st tier/large pharmaceutical companies including Pfizer, CSL Behring, Aspen Pharmacare and Sigma Healthcare. Additionally, four years of project manager/engineering experience in pharmaceutical/food/dairy design/build consultancy GEA Process Engineering Pty. Ltd.

His experience is predominately senior project management of new large +$50M sterile injectable and non-sterile OSD pharmaceutical facility builds. Inclusive for capex preparation, scheduling, major equipment tendering/procurement, GMP V model documentation, GMP/OH&S risk assessments, facility/utility CD/PD/DD and construction, equipment FAT/SAT and GMP qualification.

Moreover, lead successful regulatory submissions to Phase I FDA (PPD as CRO) and Phase 2 TFDA (EffPha as CRO).

Above listed companies/projects have entrusted Doug to lead engineering design reviews/technology transfer compliance, FATs and clinical trial batch manufacture in Copenhagen (Denmark), Bern/Schaffhausen/Aesch (Switzerland), Liverpool (UK), Bologna/Florence (Italy), Laupheim (Germany) and Osong (South Korea) among others.

Awarded “CSL Behring annual star achievement commendation for project excellence and contribution to CSL Behring”, post conclusion of $150M Privigen® Immunoglobulin (Human) project.

• Leadership and management: Successfully managed project engineering teams, external design consultants and multinational equipment suppliers to deliver requirements for major projects under both time and budget pressures.
• Project management: Excellent project management skills and expertise from conceptualization to operations handover.
• Relationship building and management: Strong ability to build and maintain relationships across all levels and departments of an organization and equipment suppliers and builders.
• Technical skills: Extensive engineering knowledge and experience in facility and equipment design, install and commissioning with specialist expertise regarding Pharmaceutical non-sterile OSD and sterile liquid facilities.
• Highly skilled in AutoCAD 2D/3D building/equipment layouts, fabrication and piping.
• GMP Qualification: Extensive experience generating and approving all GMP V-Model documentation for non-sterile OSD and sterile liquid facilities, equipment and services.
• Clinical Regulatory Submission: Successfully managed all legal and CTD submission activities respective to Phase 1 FDA (PPD as CRO), Phase 2 TFDA (EffPha as CRO) and Phase 2/3 AIFA/AEMPS (OPIS as CRO).
• Integrity: Demonstrates strong honesty/integrity. Accountable/reliable at all times.