Posted in: Other in Nebraska | Posted: |
Job Description
This role is located in Cambridge, MA or RTP, NC.
The Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products leadership role in PO&T is responsible for the process, analytical, and technology development of all biologic and advanced therapy medicinal product (ATMP) modalities including existing protein-based drugs, monoclonal antibodies, and gene therapy assets. The role has end-to-end CMC product responsibilities from pre-clinical to commercial life cycle process development activities, process platform strategies, and regulatory CMC management/filings across the biologics/ATMP modality portfolio. This role is ultimately accountable for delivering GMP-ready processes to manufacturing, phase-appropriate process optimization (i.e., COGS optimization), and regulatory CMC filing/approvability across all global healthcare regions. In addition to process and analytical development, the position oversees multi-disciplinary international teams supporting Quality oversight, CMO/CRO execution and strategy, regulatory filings, and manufacturing technology transfer. The leader guides, coaches, and develops team members to lead, collaborate, and engage in a matrix set of responsibilities with Biogen; this includes direct line reports as well as the facilitations of dotted line responsibilities of staff, and considerable partnership/alignment with Asset Development Program Management (ADPM) group.
This role sits on the PO&T leadership team, is the primary decision maker as a member of the PO&T Governance Committee (GC) for this modality, and has extensive interface and influence with critical stakeholders including Discovery & Research, Translational Sciences, and Clinical Development, external partners/collaborators representing PO&T on partner joint steering committees and various industry influencing forums.
Principle Accountabilities Include:
1. Sets the strategic direction and priorities to ensure development, delivery, life cycle, and regulatory management of programs/products in modality area of responsibility. Provides leadership, oversight, and direction to the cross-functional team responsible for the work.
2. Works cross-functionally to drive CMC strategy for products in modality area of responsibility. Identifies and resolves barriers associated with meeting CMC portfolio deliverables to ensure timelines are met. Develop CMC metrics/analytics to support decisions and development timelines. Represents PO&T in external due diligence and partnership evaluations
3. Contributes expertise to PO&T GC across the portfolio, particularly in assigned modality area. Establishes expert teams to support PO&T program or product strategy.
4. Leverages best CMC practices in the industry through professional forums and other external outreach; applies novel and forward-thinking ideas to influence Agencies.
5. Inspires others, develops and engages staff to leverage abilities, and builds a sense of belonging for the team. Manages synergy with line functions with regards to business/plan objectives, resources, and budget allocation in partnership with G&A.