Chapter Lead Analytical Development
vor 5 Monaten
The Position
Pharma Technical Development Biologics Europe brings game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective biotech drugs using cutting-edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, analytics, formulation, device and packaging. Our daily work includes authoring of regulatory documents and the transfer of development projects to the commercial organization.
We are striving for a caring and sensing network organization, which lives a culture of trust and collaboration. Our people drive innovation through their expertise, passion and "getting it done" mentality. The benefit for the patient is in the center of our thoughts and efforts.
The department 'Analytical Development and Quality Control' is responsible for analytical method development, validation and quality control testing for biopharmaceuticals from pre-IND stage (Investigational New Drug application) to BLA (Biologics License Application) and launch.
We are seeking an experienced people leader with a strong analytical development and quality background. You will be a part of a high performing, collaborative function with an open and inclusive culture.
Job Responsibilities
Direct technical and personnel management of the subordinate chapter with approx. 8 direct reports ensuring people development, training, compliance, workload organisation and recruitment and supporting personnel to continuously improve productivity.
Ensuring efficient project or "time to market" - oriented analytical support for development products and licensed products of biotechnological origin
Leading and/or assisting in the development and implementation of departmental strategies and goals
Providing support and advice on technical questions related to analytical development and QC, budget planning, investments, and resource allocation.
Collaborating closely with other departments, locations, and project teams, such as the product manufacturers, the registration, QA and the analytical partners (preclinic, IPC, analytics, commercial products, etc.)
Who you are
You bring a PhD in Analytics, Biochemistry, Pharmacy, or similar scientific qualification and have at least 8 years of experience in biopharmaceutical industry, preferably in a GMP environment, and/or pharmaceutical development of biotherapeutics across the value chain. Furthermore, you possess excellent leadership skills and proven track record in people management and collaboration. In addition you have a passion for developing people and continuous improvement of processes. Further you bring:
Strong GMP background.
Experience in development of new technologies and methods for biophysical/biochemical analysis and characterization of proteins is desirable.
Excellent verbal and written communication skills in German and English
Self-motivated, proactive, responsible, result-oriented and an excellent team player
Strong digital affinity is an advantage.
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