Analytical Project Manager
4 days ago
Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.
The Opportunity
We are seeking a skilled Analytical Project Manager to join our QC Chemistry department as a key link between our QC teams, external customers, and internal stakeholders. In this role, you will serve as the primary point of contact for QC-related matters and ensure analytical activities are executed efficiently, on time, and with the highest quality.
Key Responsibilities:
Project Coordination: Represent our team in customer project teams, core project teams, and internal QC groups.
Project Leadership: Lead cross-functional QC analytical project teams to drive progress and meet milestones.
Analytical Expertise: Oversee the coordination of method validations, transfers, and batch release schedules. Collaborate with QC subject matter experts to ensure timely execution.
Documentation and Compliance: Write, review, and approve GMP documentation, including CAPAs, deviations, CoAs, and change control cases.
Strategic Input: Advise management on QC-related matters and contribute to organizational optimization and process improvement.
Regulatory Support: Participate in regulatory inspections (e.g., DMA, FDA) and customer audits.
Relationship Building: Foster strong communication and collaboration across departments, with customers, and with external partners.
Your Profile
The ideal candidate will bring a mix of technical expertise, project coordination skills, and a proactive mindset. Key qualifications and skills include:
Education: MSc in Chemistry, Biochemistry, or a related field with 2–6 years of relevant experience; or PhD with 3 years of relevant experience.
Technical Expertise: Solid experience with analytical chemistry techniques (e.g., HPLC, CE, iCE).
Project Management: Ability to manage multiple projects, oversee milestones, and drive coordination across stakeholders.
GMP Knowledge: Experience working in cGMP settings under EU and US regulatory guidelines.
Communication Skills: Strong interpersonal skills to build relationships and effectively communicate with both internal and external stakeholders.
Fluency in English: Written and spoken. Interest in learning Danish is an advantage.
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