Stefano Berna

Clinical Manufacturing Manager at Ipsen

Based in Paris, France

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Seniority

Manager

Department

Other

Location

Paris

Industry

Pharmaceutical Manufacturing

Company size

6.5K

Contact information

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Email

1 credit

s•••••••@ipsen.com

Phone

5 credits

+33 ••• •••• ••••

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Background

About Stefano Berna

Biotech/molecular background - API development management - External manufacturing management - RNA development management - Module 3 management + Q&A for regatory sumbission worldwide- Solid experience in both analytics and formulation with focus on oral dosage forms, ophthalmics and Sterile for both small molecules and peptides- Solid experience in multiples analytical techniques for both small molecules and protein/ABs.(U/HPLC,HPLC-MS, CG, KF, DSC,TGA.)- Technical Leader - Classical stability study planning and ASAP - Orphan drugs solid experience - Experience in multinational matrix environment and CMO/CDMO/CLO coordination- Familiar with cGMP, knowledge of ICH guidelines, FDA and ANVISA regulations

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