Dr. Roman Necina

Head of Process Development

Shire

Key Achievements

Process Development, Tech Transfer, Scale-up and GMP production of drug substance and drug product for more than 40 different biological (rec. proteins, viral vaccines, gene therapy products).

Plant manager at five different sites in Europe and US.

Design, implementation, execution, and completion of capital expansion projects according to plan and budget.

Lead of three successful FDA Pre Approval Inspections at three sites (biopharmaceuticals and vaccines) and two companies, numerous successful FDA GMP inspections, and inspections by different national authorities, including Health Canada, AGES, at different sites.

Responsibility for local and global teams with more than 700 people and more than 80 Mio € annual budget