Analytical Development
vor 2 Monaten
**We are looking for...**:
....a highly motivated **Analytical Development & Quality Testing Manager **for our **Technical Operations** department.
**Your tasks**:
- 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.
**Your profile**:
- 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.
**About us**:
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 150 employees. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial or fungal infections. We have successfully launched two hospital brands, Cresemba® for the treatment of invasive fungal infections and Zevtera® for the treatment of bacterial infections. In addition, we have preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN).
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