ASO Analytical Development Director — Lead & Innovate

TalentAlly; Cambridge (MA); On-site; USD 159,000 - 219,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life insur­

401(k) with company match

Tuition reimbursement

Paid time off

Employee stock purchase plan

Wellness programs

Job summary

Biogen is seeking an Associate Director, ASO Analytical Development to lead analytical development for ASO drug substances and products. The role drives method development, control strategies, and lifecycle management while coordinating with CMC, process development, QC, and external partners.

You will develop a strategic roadmap, mentor scientists, oversee outsourced work, and contribute to regulatory submissions and technical reports, shaping analytical science across programs.

Qualifications

• PhD with 6+ years in analytical development or MS with 8+ years or BS with 10+ years.
• Experience in antisense oligonucleotide analytical development for drug substances and/or drug products.
• Familiarity with regulatory expectations, ICH guidelines, and GMP principles.
• Experience leading analytical workstreams and cross-functional CMC teams.
• Proven staff mentoring abilities.

Responsibilities

• Lead day-to-day analytical development activities for ASO programs and align with portfolio priorities.
• Develop and implement phase-appropriate analytical methods and control strategies for ASO materials and products.
• Provide technical leadership for method development, qualification, validation, transfer, and lifecycle management.
• Represent Analytical Development on cross-functional CMC and asset teams.
• Author/review analytical content for regulatory submissions and health authority responses.
• Oversee outsourced analytical work and review protocols, data, and reports.
• Mentor scientists and foster inclusive teamwork and career development.
• Develop the strategic roadmap for ASO Analytical Development including hiring and budgeting.

Skills

Analytical development leadership

Cross-functional collaboration

Regulatory submissions knowledge

Analytical method development

Team mentoring

Scientific communication

Education

PhD in analytical chemistry or related

MS in a relevant field

BS in a related field

Job description

Biogen is seeking an Associate Director, ASO Analytical Development to lead analytical development for ASO drug substances and products. The role drives method development, control strategies, and lifecycle management while coordinating with CMC, process development, QC, and external partners.

You will develop a strategic roadmap, mentor scientists, oversee outsourced work, and contribute to regulatory submissions and technical reports, shaping analytical science across programs.