Senior Lead - Small Molecule Analytical Development

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

Benefits offered by this job

401(k) match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen is seeking an Associate Director of Small Molecule Analytical Development to lead analytical strategies and method development for small molecule programs from early clinical development to commercialization.

You will guide phase-appropriate controls, oversee impurity profiles, and contribute to regulatory submissions, collaborating with Process Chemistry, Formulation, Quality, and Manufacturing to ensure robust and compliant analytics.

Qualifications

• PhD/MS/BS with extensive pharmaceutical/biotech development experience.
• Experience in small molecule analytical development including method development and validation.
• Knowledge of regulatory expectations and GMP/CMC principles.
• Experience leading analytical workstreams or cross-functional CMC activities.
• Proven mentoring and people leadership capabilities.

Responsibilities

• Lead analytical development for small molecule programs including method development, qualification, validation, transfer, and lifecycle management.
• Develop phase-appropriate analytical control strategies for identity, assays, impurities, and degradation products.
• Provide guidance on impurity identification, forced degradation, stability, and specification justification.
• Represent Analytical Development on cross-functional CMC teams and contribute to strategy and risk assessment.
• Author and review analytical content for regulatory submissions and technical documents.

Skills

Analytical chemistry

Cross-functional leadership

Regulatory submissions

Mentoring

Communication

Education

PhD in Analytical Chemistry or related

MS in a relevant scientific discipline

BS in a relevant scientific discipline

Tools

Mass spectrometry

NMR

Dissolution testing

Solid-state characterization

Job description

Biogen is seeking an Associate Director of Small Molecule Analytical Development to lead analytical strategies and method development for small molecule programs from early clinical development to commercialization.

You will guide phase-appropriate controls, oversee impurity profiles, and contribute to regulatory submissions, collaborating with Process Chemistry, Formulation, Quality, and Manufacturing to ensure robust and compliant analytics.