R&D Senior Scientist – Pharma
Kennziffer der Stelle
Operations — Engineering
3 bis 5 Jahre
Akkodis is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC.
Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics.
The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.
With a view to strengthening our team, we are looking for a:
R&D Senior Scientist - Pharma
The resource will be responsible for providing the R&D microbiological support necessary for the launch of products.
The main tasks will be:
- Assess the finished product microbiology risk
- Setup the finished product microbiology specification
- Define microbiology methods to be used for the commercial release of batches
- Demonstrate that micro test-method is suitable to the product
- Preservation of finished product
- Provide recommendations and expertize for selection of preservative system
- Coordinate assessment of microbiology risk linked to raw materials
- Define testing program for microbiology parameters for stability studies
- Define matrixing and bracketing strategy
- Provide all elements required for the constitution of the regulatory files, including potential justifications
- Compile all documentation elements in a microbiological clearance before product launch
- Ensures the product launch within the agreed time
The ideal candidate has a Degree in Scientific fields or equivalent and at least 3 years of experience in the role. Geographical mobility is required at national and international level. Knowledge of the English language is required.
Skills in project management
Technical expertise in liquid product preservation, knowledge in preservative usage
Skills in documentation writing, scientific rational
Skills in microbiology trouble: investigation, analysis, corrective action plan
Knowledge in sterile & non-sterile liquid products
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