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Job Description
About This Role
The Sr. Director and Head, Analytical Development (AD)- Small Molecules & Antisense Oligonucleotides will be responsible for leading the development and optimization of all analytical methods and control strategies for our portfolio of small molecules (SMs) and antisense oligonucleotides (ASOs) from transition from R&D through commercialization. This leader will provide in depth expertise and guidance for the characterization of SM and ASO products as part of new product development and to support comparability when required throughout the product lifecycle. This leader will also be responsible for testing existing commercial products where needed and to oversee the development of a team for early phase clinical testing under phase appropriate GMP controls.
This is a senior leadership role with oversight for ~20-25 direct FTEs and additional indirect oversight of activities within manufacturing facilities, contract laboratory organizations and R&D. This role requires excellent cross functional influencing skills and strategic vision to maintain Biogen’s position at the forefront of SMs and ASOs process development in terms of productivity and reliability. In addition, this leader will have significant responsibility for the oversight of critical sections for IND and NDAA submissions and will be accountable to respond to queries from health authorities. This role reports into the Head of Pharma Process Development and Regulatory CMC.
What You’ll Do
• Analytical Method development: Lead the development and qualification (if required) of analytical methods for SMs and ASOs
• Accountable for the establishment of processes to document and transfer analytical methods to Quality Control, external testing labs and other contract manufacturing organizations
• Product characterization to characterize new products as part of the required data to support INDs, NDA/MAA and to support comparability during the product lifecycle
• Team leadership: Provide technical and developmental leadership to a team of scientists to ensure processes are in place to manage workload, assess capacity, drive productivity and drive compliance with appropriate regulatory requirements including data integrity
• Clinical Commercial support: This leader will provide end to end support to all analytical methods in terms of driving YoY productivity, improving reliability and to support complex investigations to ensure supply in addition to managing commercial testing where required and will establish an early phase clinical testing capability
• Technology advancement: This leader will be responsible to ensure continued innovation for analytical method development for both SMs and ASOs including our platform and more complex molecules
