Head Of Product Development And Regcmc, Biologics And Advanced Therapy Medicinal Products

Job Description
This role is located in Cambridge, MA or RTP, NC.
TheHead of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Productsleadership role in PO&
T is responsible for theprocess, 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, TranslationalSciences, 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.