Ma%C3%AEtre d'h%C3%B4tel Offres d'emploi - Bâle-Ville (BS)

Analytical Project Manager

CK QLS are looking for an Analytical Project Manager to be based in Basel.

Duration :

12 months with an option for an extension.

RESPONSIBILITY AND TASKS :

The Analytical Project Manager- Vaccine is responsible for the development of analytical methods of DS and DP for vaccine projects, and the establishment of the analytical methods for Quality Control testing.

The Analytical Project Manager Vaccine will have the following responsibilities and tasks :

• State- of the art development of analytical methods for new drug substances and drug products being selected for preclinical and clinical development.
• Management of a product portfolio of approx. 2-4 projects (depending on the life cycle of the project).
• Managing analytical projects with external partners. Main contact for external sites, e.g., CMOs and CROs, for defined analytical tasks.
• Development, optimization and implementation of analytical methods, e.g., for purity-, stability-, cleaning verification / validation-, excipients-, content.
• Representation of QC department in technical project team and Product team meetings.
• Proper documentation of all analytical activities according to Good Documentation Practices.
• Review, interpretation and documentation of analytical data including results from method development, release, retest, validation, stability, and transfer.
• Write-up and review of analytical protocols and reports and establish specifications.
• Organization of GMP-(re)qualification and validation of analytical equipment with external companies.
• Independently designs and executes projects or experiments with hands on involvement.
• Establishment of source documents for IND, IMPD, and NDA / MA submissions as well as responding to agency questions and together with Technical regulatory colleagues interact with Health Authorities.
• Manage the outsourcing of analytical activities to CROs / CMOs in a compliant way including supplier selection input.
• Participate in technology transfer between laboratories, both internal and external to the company.

REQUIRED QUALIFICATIONS AND EXPERIENCE :