Biogen · 1 day ago
Director, CMC Asset Lead
Cambridge, MA
Full-time
Hybrid
Director/Executive
12+ years expBiogen is a global biotechnology company committed to delivering life-changing medicines. The CMC Asset Lead will provide cross-functional leadership for development programs, overseeing all aspects of asset strategy, development, supply, and lifecycle management for CMC components of clinical programs.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Serve as the PO&T “asset owner” for early-stage programs, with full accountability for developing and delivering a five-year PO&T Asset Strategy, maintaining an 18-month rolling Tactical Plan, monitoring key program risks, and creating risk mitigation plans
Lead the cross-functional PO&T Asset Team, which includes representatives from process and analytical development, manufacturing, quality assurance, supply chain, device (if applicable), and regulatory CMC. Guide the team in developing and implementing both the Asset Strategy and Tactical Plan
Act as PO&T’s representative on Research and Development Program teams, serving as an influencer and liaison between Research, Development, and PO&T leadership
Proactively elevate risks with the Asset Strategy, such as those driven by other assets or line function priorities, by consulting with the PO&T Governance Committee, Research/Development governance, or corporate partners
Monitor the impact of asset-related activities on the annual project budget and resources and total estimated cost to commercialization. Collaborate with PO&T Line Functions to develop tactics for cost improvement and prepare business cases for major asset initiatives, securing management endorsement from the PO&T Governance Committee
Maintain program risk register and develop and manage mitigations to keep CMC activities off critical path
Qualification
Required
An advanced degree (PhD preferable) in a relevant biopharmaceutical discipline with at least 12 years of related experience, including both line and matrix management
Proven record of effective matrix leadership within program teams through all stages of the product life cycle, such as CMC line function sub-teams or other cross-functional teams in a matrix environment
Experience with CMC activities spanning research to IND and late-stage development, and a solid understanding of global registration processes. Technical expertise in one or more areas of bio/pharmaceutical development is required
Background in the healthcare, biotech, or pharmaceutical industry, with demonstrated understanding of cross-functional interdependencies among Research, Development, commercial, regulatory, and finance functions
Strong strategic, organizational, and relationship-building skills
Ability to lead, motivate, and influence strategic direction without direct authority, leveraging and developing diverse perspectives and ideas from matrix teams and other stakeholders
Excellent communication, negotiation, problem-solving, and decision-making skills
Demonstrated ability to identify critical program risks and implement strategic or tactical mitigation plans to reduce risk, cost, and reputational impact to Biogen
Benefits
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
Pharmaceutical Technology
2026-01-05
thecanadianpressnews.ca
2025-12-24
Company data provided by crunchbase