Leader Analytical Development

For our Client regional leader in the pharmaceutical development field we are looking for a person, who will fill the position of Leader Analytical Development.

A person employed in this position will be responsible for:

• Leading a team of analytical scientists
• Supporting the development of drug products
• Development of robust, fit-for-purpose analytical control strategies, analytical method development, validation and transfer, analytical understanding for drug substance and drug product process development, scaling up and technology transfer
• Taking part in internal and external meetings with customers (local, regional and global)
• Submission and approval of Clinical Trial Applications (CTAs, IMPDs, etc.) and submission documentations to get Marketing Authorization (NDAs, MAAs, etc.) for NCEs and generic products
• Collaboration within the Analytical Development Department and with the other pharmaceutical Development departments

Our Client provides:

• Opportunity to gain experience in a stable growing company
• Work in a positive atmosphere
• Excellent training, and development

We are looking forward to meeting Candidates who have:

• Bachelors, Masters, or PhD in Analytical Chemistry
• Minimum of 4+ years of related industry experience connected with team managing
• Strong technical background in analytical chemistry is required; including direct or indirect experience with analytical technologies used routinely in the pharmaceutical industry (UPLC/HPLC, GC, UV-Vis, Karl Fischer, Mass Spectrometry, X-ray diffraction, and others)
• Demonstrated leadership of technical teams and effective cross-functional communication
• Demonstrated capability to solve critical scientific and business problems
• Demonstrated ability to implement and to grow the capabilities of an analytical organization and develop scientists into future leaders
• Extensive experience in drug substance and drug product process development, scale-up from pilot plants to commercial facilities and analytical method transfers from R&D to commercial QC testing laboratories
• Understanding of cGMP, cGLP and regulatory requirements for clinical development and marketing authorizations in Europe and preferably in the U.S. as well