Analytical Project Manager for Drug Substance and Product Methods
1 month ago
We are seeking a highly skilled Analytical Project Manager to play a key role in the implementation of test methods to support clinical phase III and Process Performance Qualification (PPQ) technology transfer programs. This exciting opportunity is based in our state-of-the-art facility in FDBD Hillerød, Denmark.
The QC department consists of approximately 230 employees divided into four departments: Analytical Development (AD), Testing Teams, Laboratory Support, and Raw Materials. You will be part of the QC AD Projects team in the AD department, working closely with seven highly skilled and dedicated colleagues.
Your primary responsibilities will include leading meetings with customers and internal QC teams to ensure prioritization of non-compendial and compendial method transfer activities according to deadlines. You will also generate transfer plans, transfer summary reports, and change control in relation to method transfers. Additionally, you will review transfer/validation/qualification protocols and reports.
As an ideal candidate, you possess a Master of Science within Pharmaceutical Sciences, Biochemistry, Protein Chemistry, Biology, or similar relevant education. You have experience with cGMP QC laboratory, pharmacopoeias, and ICH guidelines. A strong scientific background and preferably experience with method transfer and validation are essential. You must also be able to ensure strong stakeholder focus and prioritize and adapt to business needs.
This role offers a competitive salary of around $85,000 - $110,000 per year, depending on experience. We offer a dynamic work environment, opportunities for personal and professional growth, and a comprehensive benefits package.
Our company values teamwork, collaboration, and continuous improvement. We believe in empowering our employees to take ownership of their projects and make meaningful contributions to our organization. If you are a self-driven, motivated, and systematic individual who is passionate about project management, we encourage you to apply for this exciting opportunity.
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