Senior Manager, Biologics Development

Job Summary

Providing hands-on technical leadership, the full-time Senior Manager, Biologics Development will execute downstream process development activities for biologics programs, ensuring compliance with regulatory standards while collaborating with cross-functional teams and external partners in a remote environment.

Key Responsibilities

• Execute and support downstream process development activities for assigned biologics programs
• Design, develop, optimize, and characterize purification processes including chromatography and filtration
• Support technical interactions with CDMOs and ensure alignment with defined development plans

Required Qualifications

• Bachelor's degree in Chemical Engineering, Biochemistry, or Biotechnology with 10+ years of experience; OR Master's with 7+ years; OR PhD with 5+ years of relevant industry experience
• Significant expertise in biologics downstream processing (purification, protein sciences)
• At least 2-5 years of experience in supervising technical staff
• Strong knowledge of cGMP, ICH Q8/Q9/Q10, and data integrity standards
• Experience in DoE (Design of Experiments) tools and tech transfer