Director of Chemistry, Molecule Process Development and Manufacturing

Position: Director of Chemistry, Small Molecule Process Development and Manufacturing
About This Role
We are seeking a highly motivated and creative Director of Chemistry to join our Small Molecule Chemical Development team. In this role, you will lead and mentor scientific and engineering teams as you guide project progression from early-phase through late-phase drug development. You will oversee the design and refinement of robust manufacturing processes for a wide range of small molecules, supporting pre-clinical and clinical therapeutics.

This role is integral to advancing our scientific endeavors, driving innovation, and enabling the successful launch of new medicines through collaborative, safe, economical, and sustainable process development.

Who We Are

We are a team of organic chemists and chemical engineers engaged in the design of innovative processes which supply new medicines to patients. We focus on developing safe, economical, sustainable, cost-effective, and robust processes to support clinical trials and the launch of new medicines across various drug modalities. We are driven by first principles science, data-driven decision-making, and collaborative teamwork.

What You'll Do

• Lead collaborative development and manufacturing teams to design and conduct experiments to optimize and characterize the processes of Biogen assets with an emphasis on improvement in process understanding, robustness, and productivity.

• Design, guide and execute experimental plans to advance the Biogen portfolio. You will be responsible for leading project teams towards the implementation of safe, efficient and robust chemical processes Biogen drug candidates. You will collaborate with development and manufacturing teams to optimize and characterize the processes of Biogen assets with an emphasis on improvement in process understanding, robustness, and productivity.

• Responsible for managing scientific colleagues, and mentoring, engaging, and preparing our future scientific and engineering leaders

• Develop the fundamental process knowledge needed to support the transition of chemical and biochemical processes from laboratory scale to manufacturing partners.

• Collaborate with our Process Engineering, Analytical Chemistry, Oligo Synthesis, Solid Form, and Separations colleagues to develop the knowledge and controls needed for the supply of clinical materials and characterization of processes to support regulatory filings.

• Communicate project team research results effectively by in reports and discussions in team meetings, including engagement in CMC activities including authoring CMC section of INDs.

• Interact with Contract Research Organizations as project needs evolve, which may include travel

• Initiate innovative research projects to improve fundamental understanding and control of Biogen processes

• Expand on your Chemistry community presence professionally representing Biogen externally in consortia and conferences

Who You Are

You have a passion for exploring scientific concepts and are eager to contribute to the design and development and execution of cutting-edge technologies in the service of delivering drug candidates for clinical trials. Your vision and dedication drive you to push the boundaries of scientific endeavors, ultimately impacting patient lives. You thrive in a collaborative environment where urgency, accountability, inclusion and integrity are shared values.

• M.S. or PhD with 12+ years of relevant experience, including people management, in pharmaceutical or biotech settings is required

• Strong background in the theory and practice of pharmaceutical process chemistry and engineering, including command of synthetic strategies, impurity controls, analytical, purification and isolation techniques, process characterization, familiarity with process safety and tech transfer protocols, and good problem-solving skills in the service of delivering non-clinical and clinical APIs and the phase appropriate knowledge packages for CMC support.

• Demonstrated experience in leading project teams involved in delivery of APIs across several modalities

• Ability to lead teams ethically, collaboratively, effectively, and cross-functionally

• Excellent communication and interpersonal skills are required along with the…