Description
Our leading pharmaceutical company client is looking for a
Our client is looking for one Scientific Associate Analytical Development and Quality Control, working on site at their offices in Basel.
The individual will be responsible for performing lab activities related to CMC projects in terms of the development of analytical methodology and characterization of sterile drug products.
Role Responsibilities:
*Organization and execution of lab work for Idorsia's parenteral drug products
*Implementation of new analytical techniques required for parenteral drug products
*Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, content and potentially genotoxic impurity determinations
*Conduct of release and stability tests under cGMP and non-GMP
*Planning and execution of method transfers and validations including respective documentation
*Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability and transfer
*Assurance of adequate maintenance and operation of analytical equipment according to GMP
Qualifications:
*Apprenticeship, college-, or university-degree or equivalent education in the field of chemistry, biochemistry, biology, pharmacy, or chemical engineering. A minimum of 4 years of work experience in the analysis and method development for parenteral drug products.
*Skilled in the application of cGLP/cGMP.
*Extensive analytical development background and hands-on lab experience of analytics for sterile drug products.
*Experience in late phase development activities, e.g. analysis of drug product supplies for pivotal clinical trials, registration stability studies and process validation
*Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
*Prior experience with complex parenteral products and medical devices.
*Expertise in the development and validation of analytical methods used for the characterization and control of parenteral products.
*Excellent interpersonal/ organizational skills and the ability to multi-task.
*Strong oral/ written communication skills, proficiency in English. German/French is a plus.
*Computer literacy (e.g. Waters Empower, ELN).
Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.
Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +44 1727 817623 or email: mcussens@keypeople.co.uk
Tel: +41 4350 86620 or email: mark.cussens@keypeopleswitzerland.ch
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