Senior Manager Analytical Development Drug Product

Reference Number: 895697 - W
Type of placement: Permanent
Location: Switzerland, North West

Introduction:

Our client is a leading biopharmaceutical company specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. They have a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success. Thanks to their success, they are looking to onboard a Senior Manager Analytical Development Drug Product.

Main Responsibilities:

  • Responsible for the management of a group in the GMP laboratory
  • Responsible that products are delivered according to quality standards defined during development and in compliance with GMP and regulatory guidelines
  • Development, optimization and validation of analytical methods for new preclinical candidates, clinical candidates, and commercial products
  • Establishment of specifications and of analytical profiles for lNDs and NDA’s
  • Planning, coordinating and directing GMP quality control operation associated with GMP analytical tasks (e.g. release analysis, stability analysis)
  • Assuring laboratory equipment qualification
  • Provide expertise to support actively the company in matters of regulatory requirements, technology and organization
  • Ensuring compliancy for the transfer of analytical methods to the CRO/CMO
  • Representing the department in technical project teams and CMC team meetings
  • Ensuring initial and continuing training of the personnel of AD-QC and adaptation according to business needs
  • Communicating results and product quality issues to management including proposals to solve issues and preventing actions
  • Active participation in internal and external forums and conferences

Qualifications and Experience:

  • Chemist or Pharmacist with at least 8 years of GMP experience in the pharmaceutical industry
  • Proven record in managing professionals effectively in a matrix organization
  • In addition to profound skills of the GMP/regulatory requirements, a strong background in analytical chemistry is required as well as extensive expertise in dedicated analytical field
  • Experience with cleaning verification/validation processes.
  • Knowledge on testing and release of excipients
  • Strong communication skills and experience in dealing with external clients, partners as well as Health Authorities
  • Proven organizational skills; Ability to handle multiple projects and exercise good judgment in prioritizing tasks, and excellent organizational skills
  • Excellent communication, interpersonal and advocacy skills
  • An enthusiastic, self-motivating and committed approach to delivering high quality results, and the confidence and flexibility to do this in a demanding environment
  • Excellent command of English
  • Willingness to limited travel
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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