Senior Manager Analytical Development

Responsibilities

• Lead analytical strategy for Phosphorodiamidate Morpholino Oligomer and conjugated oligonucleotide development programs
• Design and oversee analytical method development, optimization, and qualification activities
• Support characterization of drug substance, intermediates, impurities, and degradation products
• Provide technical oversight of external analytical laboratories and CDMO partners
• Review analytical protocols, reports, investigations, and development documentation
• Support specification setting and lifecycle management activities
• Contribute to regulatory filings and health authority responses
• Partner with process development teams to support manufacturing scale-up and technology transfer
• Evaluate analytical risks and recommend mitigation strategies
• Drive technical decision making and provide subject matter expertise across CMC functions

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline
• 8+ years industry experience within analytical development
• Prior experience supporting oligonucleotide therapeutics
• Experience with PMO or related oligonucleotide modalities
• Experience supporting IND, CTA, BLA, or NDA submissions
• Experience with drug substance conjugates
• Previous biotech or pharmaceutical leadership experience
• Experience managing external CRO/CDMO analytical activities
• Expert Level

This is a Contract position; hybrid role based in Waltham, MA.

Pay

The pay range for this position is $80.00 - $95.00/hr.

Benefits

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)