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1–2 jobs· newest first

MSAT Process Engineer voor Cell Culture - Geel (Freelance mogelijk)New
EngiFlex · Geel, Belgium
Senior
Associate Director, Analytical Development & Quality Control
Uniquity Bio Inc. · Malvern, US+1 more
Manager

+10K new in the last hour

MSAT Process Engineer voor Cell Culture - Geel (Freelance mogelijk)

EngiFlex · Posted Nov 10, 2026

Geel, Flanders, Belgium
Senior
5+ years

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Senior MSAT Process Engineer supporting the introduction of new cell culture processes to large-scale GMP production at a biotechnological production site in Geel.

Responsibilities

Coördineren van de technology transfer van USP-processen naar GMP-productie.
Ondersteunen van productieactiviteiten op schaal voor nieuwe launches.
Opstellen van procesdocumentatie, batch records en samplingplannen.
Uitvoeren van procesanalyses, trendanalyses en monitoring van kritische parameters.
Ondersteunen van procesvalidaties en Process Performance Qualification.

Requirements

Master's in Biotechnologie
PhD in Biotechnologie

Skills

mammalian cell culture GMP process development technology transfer batch records sampling plans process validation Process Performance Qualification

Benefits

motiverend salaris
extralegale voordelen
bedrijfswagen of alternatieve vergoeding

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Associate Director, Analytical Development & Quality Control

Uniquity Bio Inc. · Posted Nov 7, 2026

Malvern, Pennsylvania, United States +1 more
Manager
10+ years

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Lead analytical development and quality control activities to support biopharmaceutical product development, characterization, manufacturing, and regulatory approval.

Locations (2)

Malvern, Pennsylvania, United States
San Diego, California, United States

Responsibilities

Develop and implement robust analytical methods
Lead method qualification, validation, and transfer
Oversee GMP and non-GMP stability studies
Manage reference standard lifecycle
Review and approve QC raw data and documentation

Requirements

Bachelor's degree or higher in analytical chemistry, biochemistry, or related scientific discipline
Nice to have: late-stage monoclonal antibody drug product development
Nice to have: PPQ
Nice to have: BLA submissions
Nice to have: drug-device combination products

Skills

analytical chemistry

protein chemistry

analytical methods

method qualification

lifecycle management

product characterization

comparability assessment

regulatory submissions

process performance qualification

Biologics License Application

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