s Pharmaceutical Operations and Technology (PO&T) Mission
With passion, purpose and partnerships, we transform scientific discoveries into advances in human healthcare and deliver quality medicines to patients whenever and wherever they need it.
Sr. Director Analytical Development
The Sr. Director, Analytical Development will lead and provide strategic and technical guidance to the Analytical Development department and directly support multiple preclinical and clinical programs overseeing bioassay, biochemical, and biophysical methods for all active programs. The incumbent will be responsible for setting goals, planning and executing a wide range of analytical methods and sample preparations for complex active programs that support Biogen Idec’s discovery and product development activities, development and control of analytical methods, specifications, testing, and reporting for all Biogen Idec products. As a senior leader within our Technical Development organization the Sr. Director, Analytical Development will drive continuous improvement e.g. product characterization, have industry wide influence and work with peers to shape the business paradigm at Biogen Idec, lead and participate on multi-disciplinary teams including Quality, Research, Manufacturing, Regulatory, Process Biochemistry, Cell Culture Development, and Formulations Development to provide clear understanding of deliverables to and from Analytical Development, and be a key interface with regulatory agencies
Sr. Director, Analytical Development responsibilities:
*Direct responsibility for bioassay development, biochemistry/biophysical method development, process analytical technology, and drug candidate characterization.
*Direct responsibility for the development of appropriate bioassay/biochemical/biophysical methods for all active programs.
*Indirect-Represent Analytical Development on cross functional and cross departmental teams in and outside of Biogen Idec.
Influential member of the Senior Technical Development team responsible for setting the broader strategy for Technical Development, not just Analytical Development.
*Indirect-Provide PO&T senior staff budget implications related to project plans
Biopharmaceutical Sciences (MFG)
*12+ years’ experience in drug discovery and pharmaceutical development.
*Prior experience interacting with worldwide regulatory agencies and effective partnerships/collaborations with leading academic institutions. *Demonstrated leadership and managerial skills.
Ph.D. in Analytical Chemistry, Biochemistry or related field
Biogen Idec - 20 months ago
Biogen Idec (NASDAQ: BIIB) is a global leader in the discovery, development and delivery of innovative therapies to improve the lives of...