Technical Project and Product Leader in Drug Substance Development and Manufacturing

A Swiss Pharmaceutical company is looking for a Technical Project Leader - Drug Substance Development & Manufacturing to join them on a 12 month contract near Basel. This role is open to EU/EFTA Citizens or those with a valid Swiss Work Permit.

Working within Drug Product Development & Manufacturing and API Development, the successful candidate will have the following responsibilities:

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.
• Working 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.
• You will do this by 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 Specification:

• 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 as to motivate and convince people without line authority
• Excellent English required (oral and written)
• Ability to deliver against challenging time and quality goal

For additional information and a confidential discussion, please apply now with an updated CV.