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Technical Project and Product Leader in Drug Substance Development and Manufacturing

Website Achieva Group Limited

Technical Project and Product Leader in Drug Substance Development And Manufacturing 

Duration: 12 months
Workload: 100%
Site: on site at Idorsia Pharmaceutical Ltd, Allschwil (Basel-Land)
Nationality: EU/EFTA Citizen or valid Swiss work Permit 
Contractor Rate: CHF 86.44 – CHF 94.91 

As Technical Project Leader:
Lead and manage development, analysis, production, and timely deliveries of drug substances (API):
 
plan, organize and administer the different aspects of the technical activities required for development, scale-up, and manufacturing of an active ingredient from preclinical development to late-stage clinical development in collaboration with functions of the Technical operations team including, Global Supply Chain, Discovery, Chemistry, Project and Life Cycle Management.
 
As Product Leader: 
Lead and manage all technical development and commercial manufacturing activities for both drug substance and drug product for assigned projects by developing and executing the overall CMC/ Product Team strategies considering all cross functional aspects and by ensuring the compliant implementation of the approved strategy within the Life Cycle Team and with involved third parties.
 
Candidate’s Requirements: 

  • Chemist or Chemical Engineer with PhD
  • Minimum 7 years of relevant experience in the pharmaceutical or chemical industry (with at least 2 years of successful performance in the role of leading cross-functional teams in pharmaceutical development and/or commercial projects)
  • Scientific expertise in the drug substance (API) development and manufacturing
  • Profound knowledge of GMP, quality control and regulations governing pharmaceutical development and production
  • Experience in the API development from Phase 1 to commercial
  • Experience in QbD, process validation and registration
  • Excellent know-how of the pharmaceutical custom manufacturing market (CMO)
  • Ability to negotiate, plan, and coordinate technical development and manufacturing activities
  • Excellent interpersonal and communication skills with the ability to adapt to rapidly changing environment
  • Excellent leadership and open personality with proven team spirit to motivate and convince people without line authority
  • Excellent English required (oral and written)
  • Ability to deliver against challenging time and quality goals

The ideal candidate has:

  • Background or experience in chemistry, for example in manufacturing, drug development, basic formulations and drug substance.
  • (Preferably) the candidate has experience in small molecules.
  • Experience in Technical matters would be highly recommended as the candidate needs to be able to discuss technical matters with the technical experts.
  • Project Management experience + lead and manage development, analysis, production, and timely deliveries of drug substances (API)
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