Site Head - Bioanalysis & Biomarkers Milano

Site Head - Bioanalysis & Biomarkers
Milano
Lombardia, Milano

Director Bioanalysis & Biomarker Services (Site Head) Type: Full-time / On-site Position Summary: The Director will oversee a team of 20 scientists, playing a critical role in advancing biomarker and bioanalytical and central lab services. This role involves strategic oversight, client engagement, method development, and ensuring the highest quality and compliance in all projects. Key Responsibilities: Leadership and Strategic Oversight: Provide expertise and strategic direction to enhance biomarker and bioanalytical services. Develop short-range and long-range operational objectives, organizational structure, staffing requirements, and succession plans. Advocate for continuous improvement of processes within the Biomarker and Bioanalytical departments. Client Engagement and Project Management: Serve as the Subject Matter Expert (SME) in biomarkers and bioanalytical services, engaging with clients to understand their needs. Present the company's capabilities to prospective clients and support the business development team by reviewing proposals, RFIs, RFPs, SOWs, and final contracts. Communicate project timelines, status, and data to Principal Investigators and clients, addressing any issues that arise. Method Development and Quality Assurance: Develop and verify LC-MS/MS methods for large molecules (proteins, antibodies, ADCs, oligonucleotides) and biomarkers in biological matrices. Facilitate method transfer from the development team to the validation team. Ensure all studies are conducted with high quality, adhering to GLP regulations and SOPs. Participate in and prepare responses for technical and quality assurance audits. Industry Engagement and Knowledge Sharing: Engage in industry technical and trade groups to elevate the company's standing and generate new business leads. Maintain up-to-date knowledge of scientific advances and regulatory changes, providing insights for strategic planning. Identify subjects for publication or presentation that showcase the company's expertise in biomarkers and bioanalysis. Team Development: Foster the growth and development of the scientific staff through coaching, mentoring, and training. Assist in training and mentoring junior scientific staff. Manage a team of 20 scientists, ensuring effective collaboration and high performance. Qualifications: Education: MSc/PhD or equivalent in biological sciences, analytical chemistry, biochemistry, or a related field. Experience: 10 years in the biotechnology or pharmaceutical industry with a strong background in biopharmaceutical testing involving biomarkers and large molecules using LC-MS/MS. Experience in a GLP environment and familiarity with FDA guidance or CLIA. Previous CRO experience is preferred. Skills: Excellent management and communication skills. Proven ability to lead a multi-disciplinary team. Strong troubleshooting and analytical skills. Detail-oriented and capable of working independently under time constraints. Efficient time management and the ability to manage multiple projects simultaneously. J-18808-Ljbffr