Location: Cambridge, MA
small molecule, RNA, oligonucleotide, and novel chemical modalities (i. e. liquid nanoparticles, next-generation peptides, etc. ). 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 pharma 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 agencies. 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 facilitation 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.
This role is located in Cambridge, MA. Qualifications Who You Are You are able to balance deep technical expertise with strategic product planning and insights. You demonstrate exceptional leadership abilities including organizational awareness, business acumen, political astuteness, influencing/negotiations, decision-making ability, conflict resolution, and demonstrated ability to influence and inspire teams. You have proven successful in managing complex development portfolios and project plans and developing internal talent as well as demonstrated success in alliance and partner management.
Required Skills MS, Ph D preferred in medical-related field Minimum of 15+ years of relevant experience in the medical industry, including product development and/or commercialization experience Must have demonstrated experience in leading/engaging others in a direct and highly matrixed and fast growing and global healthcare organization, and broad technical knowledge across multiple modalities Additional Information Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team.
We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.
Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to interaction, gender identity or expression, interactionual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States. PDN-9a692b6f-bab4-4c98-9990-c2857439c343For more details: jobs-search.
org/manufacturing_cambridge-c434666/head-of-product-development-regcmc-pharma-cambridge_i1959027024
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