Your new role
As Analytical Sciences & Technology Manager, you will be leading MSAT Analytical Activities, including IPC, release and stability testing at CMOs and ensuring appropriate analytical methods validation status and its robustness. You will act as a SME for the analytical methods tech transfer for legacy products and NPI between external suppliers (CMOs), that includes planning, document preparation, execution, GxP and regulatory compliance, change control management, risk assessment, stability study management and resolution of technical issues through troubleshooting.
Our client has a vast network of clients and suppliers across Europe, which allows you to visit these clients from time to time. This also allows for a mainly remote working style, as most communication is between CMOs who are dotted all around Europe via video conferences. There is an office in Amsterdam that can be availed of.
What you’ll need to succeed
The successful candidate should have completed an M.Sc. Education in Pharmacy, Life Science or Chemistry with a minimum of 8-10 years experience working in pharma, preferably in MSAT/ASAT, QC, R&D. Background experience working with small molecules within pharmaceutical manufacturing is highly preferable.
- Knowledge of EU-GMP regulations, international regulatory requirements in pharmaceuticals and medical devices.
- Knowledge on authoring risk assessments like Nitrosamine, Extractables and Leachables, Elemental impurities, regulatory documents, change controls, protocols and reports.
- Fluent in English.
What you’ll get in return
After the successful interview rounds, you will start directly on a 1 year contract with our client. There is a high probability for this position to become permanent in future, dependent on business needs and performance reviews.
Your new company
Our client is a specialized life sciences company with a proud 130-year heritage focused exclusively on Ophthalmology. As a Japan-originated, global company with a footprint in over 60 countries, they are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.
What you need to do nowIf you are interested in this role as Analytical Sciences & Technology Manager, click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion about your career.
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