Director, Biologics Analytical RD

1 month ago

Chicago, United States Meet Full time

Job Title: Director, Biologics Analytical R&D

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. The ideal candidate will possess extensive knowledge of analytical methodologies, strong leadership skills, and a proven track record in biologics development.

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

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