Active Pharmaceutical Ingredient Lead
- Improving and maintaining API process understanding (knowledge), capability, quality, compliance and cost.
- Developing and execution of a Technical Life Cycle strategy which is consistent with future regulatory expectations and the commercial ambition for the API.
- Contribute to Supplier Relationship Management for strategic API suppliers ensuring reliable and efficient sourcing of API to manufacturing sites. Support deployment of Lean / 6 sigma methodologies in the API value stream when applicable. Maintains an overview of the process performance through data trending and CPV to ensure process(es) are in control and capable.
- Drive the API sourcing strategy including internal vs external manufacturing, single vs dual sourcing, and business partner selection.
- Lead or support projects to establish new or alternate sources of API. In particular lead the multidisciplinary Ferring project teams (regulatory, quality, finance, supply chain) and coordinate interaction with the local teams.
- Support the implementation of changes/improvements at the manufacturer of the urinary derived APIs that will generate increased quality a reduction of the manufacturing costs and possibly of the supply price.
- Provide leadership and Product Supply coordination for new API introductions ensuring focus on quality requirements, cost-efficiency, supply, sustainability and manufacturing strategy in close collaboration with Development.
- Improve process design and control strategies using data driven methodologies (modelling, data mining, DoE, QbD etc.). Knowledge sharing, training and transfer to the Ferring network
- Minimum M.Sc. in Chemical Engineering, Chemistry, Pharmacy or Biotechnology, preferably with a PhD.
- At least 8 years of experience within of development or production of API
- Familiar with manufacturing of synthetic peptides, proteins and small molecules will be an asset
- Excellent technical/scientific skills and knowledge
- Experiences with project management, Risk management and GMP is required
- English fluent (verbal & written)
- Good communication (both written/verbal) and listening skills; an ability to persuade others by using evidence (facts and figures) to justify arguments
- Good influencing and negotiation skills
- Ability to represent the business to the customer/external stakeholders
- Ability to work well as an integral part of a large Project Team, a team player, task oriented and keen on working in a cross-cultural working environment towards set objectives
- Agile and with humor
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