Senior Manager, Specialized Chemical Development - Remote

Overview

The Sr. Manager, Specialized Chemical Development will support assigned process chemistry activities for drug substance (DS), DS intermediates and starting materials, focusing initially on an oligonucleotide project.

In Short

• Support/manage process development activities and API scale-up for drug substance projects.
• Participate in external cGMP manufacturing of drug substances.
• Collaborate with internal and external partners to ensure operational excellence.
• Evaluate and select CDMOs based on capabilities and compliance.
• Develop strong relationships with CDMO business partners.
• Review and author technical documents for regulatory submissions.
• Monitor vendor relationships and establish risk mitigation plans.
• Represent Technical Operations in meetings with regulatory authorities.
• May provide on-site coverage during critical manufacturing events.

Requirements

• PhD or equivalent with 3+ years or Bachelors/Masters with 8+ years of experience in pharmaceutical process research.
• Familiarity with analytical techniques and manufacturing operations for oligonucleotides.
• Experience in vendor/supplier management and cross-functional collaboration.
• Competency in project planning and execution.
• Strong oral and written communication skills.
• Knowledge of drug development processes and regulatory requirements.
• Ability to travel up to 25% to domestic and international sites.
• Fluency with MS Office and statistical tools.

Benefits

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, and vision insurance.
• 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.
• Opportunities for personal and professional growth.