Associate Director, Downstream Biologics Drug Substance

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA. We are a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases.

Requirements

• A degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline with 8+ years of relevant industry experience.
• Proven expertise in downstream development and manufacturing of monoclonal antibodies, including both early (Phase 1/2) and late-stage (Phase 3/commercial) programs.
• In-depth experience with chromatography, filtration, and viral clearance operations.
• Strong understanding of process scale-up, tech transfer and validation activities
• Hands-on experience working with CDMOs or external partners in development and GMP manufacturing settings.
• Familiarity with Quality by Design (QbD), DoE, and statistical data analysis tools.
• Hands-on experience supporting regulatory filings.
• Working knowledge of relevant regulatory guidance (ICH, FDA, EMA) for biologics development.
• Excellent communication, leadership, and cross-functional collaboration skills.
• Ability to travel domestically and internationally up to 25%.

Benefits

• Comprehensive benefits
• Competitive compensation packages