Parenterals Manufacturing Manager Biologics MSAT

gloor&lang AG; Neuenburg; Hybrid; Vertraulich; Vollzeit

Zusammenfassung

gloor&lang AG seeks an experienced MSAT professional for a 6‑month contract in Biologics Drug Product manufacturing, focused on sterile Fill & Finish. The role requires hands‑on expertise, strong deviation handling, and collaboration with CMOs to maintain GMP standards.

You will apply CPV, trending, and risk tools while supporting process robustness and continuous improvement in a regulated biologics environment. 50% on-site in Neuchâtel is expected, with ASAP start and potential extension.

Qualifikationen

• Scientific, pharmaceutical or engineering degree.
• At least 5 years in sterile/parenteral Drug Product manufacturing.
• Hands-on knowledge of compounding and Fill & Finish with vials, STs or cartridges.
• Experience with deviation investigations, root cause analysis and CAPAs.
• Understanding of aseptic processing, GMP and regulatory requirements.
• Familiarity with risk tools like pFMEA / Ishikawa and process trending.

Aufgaben

• Provide MSAT support for commercial sterile Drug Product manufacturing incl. parenteral filling.
• Lead deviations and investigations with root-cause analysis and CAPA definitions.
• Support CPV and process capability/trending activities.
• Assess manufacturing changes from technical and product-impact perspectives.
• Review technical documentation and manufacturing data.
• Support process robustness and continuous improvement activities.
• Collaborate with cross-functional teams and external CMOs.

Kenntnisse

MSAT experience

Sterile drug product

Fill & Finish

Deviation investigations

CPV / process trending

CAPA actions

Ausbildung

Scientific degree

Pharmaceutical or engineering background

Tools

Minitab

JMP

Jobbeschreibung

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