Category

Description

Tasks:

Responsible for the management of the GMP laboratory and employees
Responsible for the analytical expertise for defined drug substances/drug products
Development, optimization and validation of analytical methods
Actively seek for technical and scientific solutions to improve quality and productivity
Establishment of analytical profiles for IND's and NDA's
Planning, coordinating and directing GMP quality control operation associated with GMP analytical tasks
Assuring laboratory equipment qualification
Compliant transfer of analytical methods to the CRO/CMO
Representing the department in CMC team meetings
Ensuring initial and continuing training of the personnel of AD-QC and adaptation according to business needs
Communication of product quality issues to management

Qualification:

Chemist or Pharmacist with at least 5 years of GMP experience in the pharmaceutical industry
Demonstrated success in a managerial leadership function
Profound knowledge of the GMP/regulatory requirements
Profound knowledge of genotoxic impurities(GTIs) and potential genotoxic impurities (PGIs)

Strong background in analytical chemistry
Business fluency in English, French and German are an asset

General Requirements:

Start: asap / latest mid of November
Duration: 6 months
Capacity: ideally 5 days / week, 4 days is also ok
Location: Area Basel, Switzerland (1 day remote is okay)

Job Details
Seniority Level
Mid-Senior level

Industry
Pharmaceuticals
Employment Type
Contract

Job Functions
Consulting

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