Senior Leader, Small Molecule Analytics & Development

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

Benefits offered by this job

Medical, Dental, Vision insurances

401(k) matching program

Tuition reimbursement

Job summary

Biogen is seeking an Associate Director to lead Small Molecule Analytical Development, guiding method development, validation, and lifecycle management for clinical and commercial programs. You will drive impurity control, specifications, and regulatory readiness while mentoring a team of scientists.

The role requires strong collaboration across process chemistry, formulation, quality, and regulatory CMC, with a focus on robust analytical strategies and data-driven decisions.

Qualifications

• Ph.D. in Analytical Chemistry or related field with 6+ years in pharma/biotech development.
• MS with 8+ years or BS with 10+ years in pharma/biotech development.
• Experience in small molecule analytical development and regulatory awareness.
• Experience leading workstreams and mentoring scientific staff.
• Strong written and verbal communication for technical audiences.

Responsibilities

• Lead analytical development activities for small molecule programs from discovery to commercialization.
• Develop phase-appropriate analytical control strategies for identity, impurities, and dissolution.
• Provide guidance on impurity identification, degradation, and specification justification.
• Represent Analytical Development on CMC project teams and regulatory documents.
• Author/review content for INDs, CTAs, NDAs/MAAs, and technical reports.
• Collaborate with cross‑functional teams to align methods with process understanding.

Skills

Analytical development

Leadership

Regulatory submissions

Communication skills

Education

Ph.D. in Analytical Chemistry

M.S. in a scientific discipline

B.S. in a scientific discipline

Tools

Mass spectrometry

NMR

Solid-state characterization

Dissolution testing

Job description

Biogen is seeking an Associate Director to lead Small Molecule Analytical Development, guiding method development, validation, and lifecycle management for clinical and commercial programs. You will drive impurity control, specifications, and regulatory readiness while mentoring a team of scientists.

The role requires strong collaboration across process chemistry, formulation, quality, and regulatory CMC, with a focus on robust analytical strategies and data-driven decisions.