Leader, Small Molecule Analytical Development

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

Benefits offered by this job

Medical, Dental, Vision

Wellness programs

Vacation and holidays

Parental and maternity leave

401(k) with company match

Employee stock purchase plan

Tuition reimbursement

Job summary

Biogen, Inc. in Cambridge, MA seeks an Associate Director, Small Molecule Analytical Development to lead analytical development for small molecule programs from early clinical development through commercialization.

You will develop phase-appropriate analytical strategies, oversee method development and validation, support impurity control and specification setting, and contribute to CMC regulatory submissions.

Qualifications

• Ph.D. with 6+ years (or MS with 8+ years or BS with 10+ years) in pharma/biotech development.
• Experience in small molecule analytical development including method development, validation, transfer, impurity profiling, stability and specification setting.
• Proven ability to lead analytical workstreams, cross-functional teams, and mentorship of scientific staff.

Responsibilities

• Lead analytical development activities for small molecule programs including method development, qualification, validation, transfer, lifecycle management, and control strategy support.
• Develop and implement phase-appropriate analytical control strategies for identity, assay, impurities, degradation products, residual solvents, and other critical quality attributes.
• Provide technical guidance on impurity identification, forced degradation, stability strategy, and specification justification.

Skills

Analytical Development

Cross-functional Leadership

Regulatory Submissions

Team Leadership

Project Management

Scientific Communication

Education

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, Chemistry, Chemical Engineering or related field

Tools

Mass Spectrometry

NMR

Solid-State Characterization

Job description

Biogen, Inc. in Cambridge, MA seeks an Associate Director, Small Molecule Analytical Development to lead analytical development for small molecule programs from early clinical development through commercialization.

You will develop phase-appropriate analytical strategies, oversee method development and validation, support impurity control and specification setting, and contribute to CMC regulatory submissions.