Beschreibung

Senior MSAT Principal Scientist – Biologics Fill & Finish
Biologics Drug Product | Sterile Manufacturing | 6-month contract
Our customer is a leading international biopharmaceutical company with a strong manufacturing presence in Switzerland. We are looking for an experienced MSAT professional with hands-on expertise in commercial biologics Drug Product manufacturing and sterile Fill & Finish.
Your responsibilities
Provide MSAT support for commercial sterile Drug Product manufacturing, including parenteral compounding and filling
Lead manufacturing deviations and investigations, including root cause analysis, product impact assessment and CAPA definition
Support Continuous Process Verification (CPV) and process capability/trending activities
Assess manufacturing and process changes from a technical and product-impact perspective
Review technical documentation and manufacturing data
Support process robustness and continuous improvement activities
Collaborate with cross-functional teams and external manufacturing partners/CMOs
Your profile
Scientific, pharmaceutical or engineering degree
At least 5 years of relevant experience in sterile/parenteral Drug Product manufacturing
Strong hands-on knowledge of compounding and Fill & Finish, ideally involving vials, pre-filled syringes and/or cartridges
Strong experience with deviation investigations, root cause analysis, CAPAs and change control
Good understanding of aseptic processing, GMP and global regulatory requirements
Experience with risk assessment tools such as pFMEA / Ishikawa
Experience with CPV, process trending and statistical tools such as Minitab or JMP is an advantage
Fluent English; French is an advantage
You are a pragmatic and solution-oriented MSAT professional who enjoys working close to manufacturing and solving complex technical issues in a highly regulated biologics environment.
Location: Switzerland / Neuchatel – approx. 50% on site
Start: ASAP
Duration: 6 months, with possible extension jpid97c5a6fob jpit0833ob jpiy26ob