Technical Project and Product Leader in Drug Subst
QLS are recruiting for a Technical Project and Product Leader Development and Manufacturing DS to join an innovative Pharmaceutical company on a contract basis for 12 months.
Home office: 3 days on-site two days working from home possible
Job 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 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 Phase1 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 activitie• 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 goals
Apply: For more information or to apply for this position, please contact Adrien on 0041 (0) 800 106 106 or email aguimard@ckqls.ch. Please could you send any correspondence in English. Please quote job reference 56626 in all correspondence.
