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Director of Biologics Analytical Research and Development
2 months ago
Meet is a global pharmaceutical company dedicated to advancing healthcare through innovative therapies and cutting-edge research. We are committed to improving patient outcomes by developing biologic products that address unmet medical needs.
Position Overview: We are seeking a highly experienced and dynamic Director of Biologics Analytical Research and Development (R&D) to lead our analytical team in the development and characterization of biologic products. This role will be instrumental in shaping our biologics portfolio and ensuring compliance with regulatory standards.
Key Responsibilities:
- Strategic Leadership: Develop and execute the strategic vision for the Biologics Analytical R&D team, aligning with overall corporate goals and objectives.
- Team Management: Lead, mentor, and develop a high-performing team of scientists and researchers, fostering a culture of innovation, collaboration, and excellence.
- Analytical Method Development: Oversee the development, validation, and implementation of robust analytical methods for the characterization and stability of biologic products.
- Regulatory Compliance: Ensure that all analytical activities adhere to regulatory requirements and industry standards, including GLP, GMP, and ICH guidelines.
- Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Process Development, Quality Assurance, and Regulatory Affairs, to support biologic product development from preclinical through commercialization.
- Technical Expertise: Provide expert guidance on complex analytical issues, troubleshoot challenges, and drive the development of innovative solutions.
- Budget Management: Manage departmental budget and resources efficiently, ensuring the alignment of project priorities with organizational goals.
- Stakeholder Engagement: Communicate effectively with internal and external stakeholders, including presenting findings to senior management and participating in regulatory meetings.
Qualifications:
- Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or a related field.
- 10+ years of experience in analytical development for biologics, with a focus on monoclonal antibodies, proteins, or similar products.
- Proven leadership experience in a managerial role within a pharmaceutical or biotech environment.
- In-depth knowledge of regulatory guidelines and quality standards governing biologics.
- Strong analytical thinking, problem-solving skills, and attention to detail.
- Excellent communication and interpersonal skills, with the ability to influence and collaborate across diverse teams.
- Experience with advanced analytical techniques such as HPLC, Mass Spectrometry, and ELISA.
