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Analytical Project Manager

Job Field:
Regulatory and Drug Safety Jobs
Drug Safety Jobs, Regulatory Affairs Jobs
Switzerland All
Contract Type:
Salary Description:
Job Ref:
SWI APM 270317 AD

Analytical Project Manager- near Lucerne, Switzerland - Permanent

Clintec Zug is actively recruiting for an Analytical Project Manager to join our expanding global company in Switzerland. This opportunity is permanent and will be dedicated to our global client, working from their bitoechnology facility based near Lucerne.

Role Description:

The incumbent is responsible for monitoring of analytical GMP projects outsourced to CROs (release/ stalbility testing of DS/DP for usage in clinical trials), ensuring the timeliness and GMP compliance across multiple analytical projects and liasing with international CROs/ CMOs.

Furthermore, the job holder contributes proactively to regulatory IND filings, BLA filings and the preparation of CTDs. The role implicates a strong interaction with quality departments, R&D departments and Regulatory Affairs departments and requires a limited amount of travelling.

Responsibilities of the Analytical PM:

Planning and implementation of analytical projects conducted both locally and in cooperation with international service providers
Setup and approval of analytical release and stability testing projects in the RLIMS in the roles of specification and stability administrator, supervisor and analyst.
Provide guidelines to CROs as the company representative
Review analytical data to ensure they meet company standards
Review and approve method validation plans and summaries generated at Contract Research Organisations
Coordinate analytical issues within the global biologics network.
Prepare and execute analytical method transfers between a variety of CROs and company organizations.
Support in-house analytical activities when needed

Essential Criteria:

Engineer with relevant industry experience.
Experience with drug substance and drug product release, stability and characterization for biologics.
Experience with analytical method validation and transfers.
Strong project management and organizational skills.
Strong oral and written communication skills in English and German.

Desirable Criteria:

Ms. or Ph.D. in Biochemistry/Biological Sciences or equivalent, with relevant Biotech or Pharmaceutical industry experience.
Experience with working as part of cross functional/cross divisional teams.
Experience working with contract laboratories.

Company Information:

Clintec AG in Zug is a global CRO present in over 40 countries worldwide. We are currently working on strategic assignments as a pharmaceutical service provider with several major multinational pharmaceutical companies in Switzerland. As part of our expansion to our established team in Switzerland, we have a number of exciting opportunities available.

By working for Clintec you will have exposure to interesting assignments with leading players in global pharma R&D, and hence you can further your career in a dynamic, stable environment where you can be assured of rewarding benefits.

Closing Date:

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