Analytical Development

vor 5 Monaten

Allschwil, Schweiz Basilea Pharmaceutica International Vollzeit

**We are looking for...**:
...a highly motivated
**Analytical Development & Quality Testing Manager **for our
**Technical Operations** department.

**Your tasks**:

- Select and manage providers of analytical services, including analytical services embedded in contract manufacturing organizations (CMOs).
- Provide analytical oversight of external vendors for API and finished dose CMC analytical activities for small molecule drug substance (DS) and drug product (DP).
- Provide expertise in handling and statistical evaluation of release and stability data (Minitab, ScienceCloud)
- 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.
- 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
- Actively contribute to CMC and project teams, and ensure alignment of analytical activities with the project development plans.

**Your profile**:

- University degree in Chemistry, Analytics, Pharmacy or equivalent with minimum 3 years of analytical development work experience in the Pharma industry
- Experience in the administration of analytical data in electronical systems, e.g. ScienceCloud
- Experience in statistical evaluation of Release and stability data of pharmaceutical drug substances and drug products, e.g. Minitab
- Experience in outsourcing cGMP method development and validation/transfer to release laboratories
- 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 revenue-generating, commercial-stage Swiss biopharmaceutical company. Our activities are focused in the areas of hospital antibiotics and hospital antifungals. Our portfolio comprises of two marketed anti-infective brands (Cresemba® and Zevtera®) and several preclinical anti-infective assets. We are building on our potential for sustainable growth and valuation generation, based on increasing revenues and selective investments into internal and external innovation. Basilea was founded in 2000 and is located in the life sciences hub of the Basel area. Basilea has about 150 employees. Since 2004, Basilea is listed on the SIX Swiss Stock Exchange with the ticker symbol BSLN.

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