CMC Asset Lead, Associate Director (Biopharma, Hybrid)

Biogen, Inc.; Cambridge (MA); Hybrid; USD 163,000 - 225,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

Short- and Long-Term Disability

15 days paid vacation + year-end

Up to 12 company paid holidays + 3个人al

Tuition reimbursement up to $10,000

401(k) with company match

Employee stock purchase plan

Job summary

Biogen, Inc. seeks an experienced CMC Asset Lead at Associate Director level to guide end-to-end asset leadership for clinical programs.

You will chair a cross-functional PO&T team spanning process development, manufacturing, quality, supply chain and regulatory CMC, driving strategic planning and risk management in a collaborative biopharma setting. The role emphasizes alliance management with partners, leadership within ADPM, and influence across Research, Development and PO&T leadership as

Qualifications

• Advanced degree (PhD preferred) with 8 years of relevant experience, including line and matrix management.
• MS, MBA and/or Bachelor's degree may be considered with extensive experience.
• Matrix leadership across cross-functional program teams in a biopharma context.
• Experience with CMC in research to NDA/BLA and technical bio/pharma development.
• Experience in healthcare/biotech/pharmaceutical industry with cross-functional interdependencies.
• Excellent strategic, organizational, and relationship development skills.
• Demonstrated ability to lead, influence and drive strategic direction in matrix settings.

Responsibilities

• Lead the cross-functional PO&T Asset Team across process development, manufacturing, quality, supply chain, device, and regulatory CMC.
• Develop and deliver a 5-year PO&T Asset Strategy and an 18-month rolling Tactical Plan.
• Serve as the asset owner on clinical programs and coordinate with Research and Development leadership.
• Identify and mitigate asset risks; manage conflicts with other assets and line functions.
• Develop business cases for asset initiatives and seek endorsement from the Governance Committee.
• Monitor budget impacts and collaborate to improve cost to commercialization.

Skills

CMC drug development

Cross-functional leadership

Matrix leadership

Risk management

Communication

Negotiation

Problem solving

Forecasting

Education

PhD

MS

MBA

Bachelor's degree

Job description

Biogen, Inc. seeks an experienced CMC Asset Lead at Associate Director level to guide end-to-end asset leadership for clinical programs.

You will chair a cross-functional PO&T team spanning process development, manufacturing, quality, supply chain and regulatory CMC, driving strategic planning and risk management in a collaborative biopharma setting. The role emphasizes alliance management with partners, leadership within ADPM, and influence across Research, Development and PO&T leadership as