We are currently recruiting for a Contingent Manager ADQC (vaccines) to join our client, a leading pharmaceutical company, based in Allschwil, Switzerland.  Within this role you will be responsible for the development of analytical methods of Drug Substance and Drug Product for vaccine projects and establish analytical methods for quality control testing.  You will also ensure that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines.

• Contract Duration: 12 months with potential to extend
• Schedule: 80-100%
• Hourly Rate: CHF 77.96

Responsibilities Include:

• Responsible for the 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 live 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, and potentially genotoxic impurity determinations as well as write-up of these documents for implementation.
• Representation of QC department in technical project team and Product team meetings
• Drafting and review of CoAs, Analytical results sheets, specifications, SOPs, GUIs, TPLs

Required Qualifications and Experience:

• College, or university degree or equivalent education in the field of chemistry, biochemistry,
  pharmacy, biology or chemical engineering required with:
  • 10+ years BS, 9+ years MS or 2+ years PhD experience in the pharmaceutical industry with
  demonstrated previous success in a project management function.
• In addition to knowledge of the GMP/regulatory requirements, a strong background in vaccine development needed.
• Strong personality and disposition to manage professionals effectively in a matrix system.
• Diligent attention to details. Willingness to limited travel. Mature stable person with a positive and dynamic demeanour. High flexibility, superior communication, time-management and team-working skills. Ability to work independently and to take initiative. Excellent oral and written skills in English. Life-long learning mindset and a strong sense of accountability. Should actively seek for technical and scientific solutions to improve quality and productivity.
• Ability to complete assignments, meeting quality and timeline objectives. Strong skills in timeline development and management.
• Excellent problem-solving skills, excellent team-player, including an ability to work with diverse teams of people with multiple perspectives and talents
• Broad knowledge in analytical techniques for characterization of vaccine and in chemistry is a plus (HPLC-UV, HPLC-MS, GC-MS, NMR, Spectroscopy, wet chemistry, Dissolution). Sound knowledge in synthetic chemistry, drug substance processing and/or formulation
  development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug substance or product development. Experience in the development and performance of analytical tests for a variety of drug substances and products.