Analytical Development
vor 24 Stunden
- Actively contribute to CMC and project operation team and collaborate with multifunctional teams within Basilea and externally with partners.
- Oversee, monitor and drive outsourced analytical studies for chosen Basilea projects
- Write analytical overview reports and support writing/updating of development sections of regulatory documents (e.g. CTD).
- Select and manage providers of analytical services, including analytical services embedded in contract manufacturing organizations (CMOs).
- Ensure acquisition of know-how and maintaining a profound expertise especially in analytical methodology, technology and regulatory guidelines.
- Provide analytical oversight of external vendors for API and finished dose CMC analytical activities for small molecule drug substance (DS) and drug product (DP).
- Design and oversee the development, validation and transfer of phase appropriate analytical methods for raw materials, in-process control, DS and DP testing and ensure the availability of all required documentation.
- As a continuous approach, verify and challenges existing methods, processes, validations and activities to identify and improve existing time-consuming CMO procedures.
- Oversee solid state activities and in-vitro dissolution activities for Basilea’s portfolio
- Participate in the development and revision of product specifications, providing expert level guidance in accord with current regulatory requirements
- Support cost center head for budgeting and cost monitoring as well as lean in work order and billing.
- University degree in Chemistry, Analytics, Pharmacy including PhD or equivalent with minimum 6 years of analytical development work experience in the Pharma industry
- CMC Experience in managing analytical development for small molecule drug substance and drug product at third party vendors
- Experience with a broad range of analytical techniques and regulatory requirements for characterization of pharmaceutical drug substance including HPLC & GC with a variety of detection methods, spectroscopic techniques, particle size analysis.
- Full understanding of the chemical, solid state and formulation development of a drug to identify and document critical factors which impact analytical activities.
- Experience with the analytical techniques and US & EU pharmaceutical regulatory requirements for characterization of all compounds used towards a new drug including regulatory submission.
- Ability to strategically plan, organize and manage multiple projects simultaneously with proactive, critical analysis of technical and non-technical problems, taking appropriate actions for resolution, including excellent communication skills at different levels and independent decision making.
- Ability to work both independently and collaboratively in a team environment and to positively resolve conflict, to write clear and concise technical reports and other business correspondence.
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