For our client, a globally active pharmaceutical company in the Basel area, we are looking for a temporary assignment
Expert Biologics Analytical Operations
As expert, you are supporting the release and stability strategy, the method validation and method transfer activities for our products covering development activities.
You will support the operational aspects of GMP testing of Biologics clinical drug substances (DS) and drug products (DP). You independently manage your activities and provide required documentation according to agreed timelines and standards.
- Responsible for the successful delivery of work packages to support GMP testing of Biologics clinical drug substances (DS) and drug products (DP) for release/stability/validation/transfer
- Author and/or review of technical source documents in accordance with project timelines for global submissions.
- Review high-quality CMC documentation for HA submission.
- Well-developed planning, organizational, problem solving and interpersonal skills.
- Good communication skills with a collaborative and patient-focused mindset
- Computer/IT systems literacy
- Education Minimum: Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Molecular Biology, Biotechnology, Biology) or equivalent; advanced degree desired.
- Minimum 2 years of Quality Control experience in a GMP environment and/or pharmaceutical industry experience.
- Sound technical and scientific knowledge of pharmaceutical development and analytical sciences.
- Knowledge on health authority regulations.
- Proven ability to critically evaluate data from a broad range of scientific disciplines.
- Proficient in English (other languages are a plus).
Working Time: flexible working hours
Start Date: ASAP
Duration: 14 month
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Franck Maerky (+41 61 270 80 17).
We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers. Kelly Services Switzerland is acting as an Employment Business in relation to this vacancy