Category

Description

Your main tasks:

Responsible for the management of a GMP-laboratory and up to 2 employees. This includes planning, coordinating and directing GMP quality control operation associated with GMP analytical tasks (e.g. release analysis, stability analysis)
Ensuring optimal development, optimization and validation of analytical methods for new preclinical drug candidates and commercial products
Establishment of specifications and of analytical profiles for IND's and NDA's
Assuring laboratory equipment qualification
Ensuring compliancy for the transfer of analytical methods to the CRO/CMO
Representing analytics team in technical project team and CMC team meetings
Ensuring initial and continuing training of the laboratory personnel
Communicating results and product quality issues to management

Your background
University degree (preferably PhD) in chemistry
5-10 years of work experience in the pharmaceutical industry in a GMP environment is a must
Good knowledge of HPLC, GC and NMR is a must
Good stakeholder management and collaboration skills, you are able to speak up and convince your audience during technical meetings
Fluency in English

Job Details
Seniority Level
Associate

Industry
Biotechnology Pharmaceuticals
Employment Type
Full-time

Job Functions
Science Health Care Provider

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