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Senior Director of Biopharmaceutical Research and Development

2 months ago

Oak Park, Michigan, United States Jobot Full time
About the Role

We are seeking an experienced R&D leader to join our team as a Vice President of R&D for Biologics Process Development. This is a unique opportunity to lead a cross-functional team of scientists in the design, optimization, and development of novel therapeutics.

Key Responsibilities
  • Provide strategic leadership and direction for the department, driving innovation and excellence in biologics process development.
  • Develop and execute client projects that require process development, method development, and optimization for monoclonal antibodies, bispecific antibodies, cytokine fusion molecules, and other recombinant therapeutic proteins.
  • Lead a team of scientists in the design, optimization, and development of novel therapeutics, including cell banking, upstream cell culture, and downstream purification.
  • Contribute to planning synthetic routes for chemical synthesis projects in bioconjugation, ensuring bioconjugation processes control for API integrity as required by cGMP, ICH, and FDA regulations.
  • Author and review relevant sections of white papers, thought leadership articles, regulatory filings, IND/IMPD, BLA, etc.
  • Stay abreast of the latest advancements in research, therapeutic modalities, and industry trends, integrating new knowledge into Biologics Process Development strategies and programs.
Requirements
  • MS/Ph.D. in Biochemistry, Chemistry, Pharmaceutical Sciences, or a related field; MBA or other advanced degrees preferred.
  • Minimum of 10 years of progressive leadership experience in the biopharmaceutical industry, with a focus on antibody processing and bioconjugation research and development.
  • Proven track record of successfully leading process development teams and driving the development of novel therapeutics from concept to commercialization, preferably in the conjugation space.
  • Deep expertise in bioconjugation technologies, including antibody engineering, linker chemistry, payload conjugation, and analytical characterization.
  • Strong understanding of preclinical and clinical development processes, regulatory requirements, and CMC considerations.
  • Exceptional communication, negotiation, and presentation skills, with the ability to engage and influence stakeholders at all levels of the organization.
What We Offer
  • Medical, Dental and Vision insurance
  • Annual Bonus
  • Company paid holidays
  • Generous PTO
  • 401k with company match