Associate Director, Downstream Biologics Drug Substance

Role Summary

Associate Director (AD) Downstream Biologics Drug Substance (BDS) responsible for leading design, optimization, and scale-up of downstream processes for antibodies and proteins across early to late development, including CDMO oversight, tech transfer, process characterization, validation, and regulatory filings.

Responsibilities

• Lead downstream process development for biologic programs from preclinical through late-stage development, ensuring scalability, robustness, and product quality.
• Lead tech transfer to CDMO manufacturing sites, ensuring successful execution at pilot and large scale.
• Design and direct process characterization studies, define control strategies, support PPQ, and technology transfer.
• Support downstream related investigations, CAPAs and process improvement initiatives.
• Provide technical oversight for viral clearance studies and ensure alignment with regulatory expectations.
• Contribute to defining process control strategies and lifecycle management plans in alignment with relevant guidelines.
• Author and review key technical and development reports, risk assessments, and regulatory submission documents (IND, IMPD, BLA).
• Partner with relevant stakeholders to ensure seamless integration of drug substance activities.
• Support CDMO selection, oversight, and technical governance ‚Äî including remote and on-site presence as required (approximately 25% travel).
• Foster technical excellence and innovation within the drug substance team.
• Ensure compliance with company and regulatory standards for documentation, data integrity, and safety.
• Engage with CMC and/or Executive Leadership to proactively identify technical risks and provide scientific recommendations for mitigation plans.
• Contribute to a positive workplace culture that prioritizes collaboration, accountability, and continuous improvement.

Qualifications

• A degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline with 8+ years of relevant industry experience. MS or PhD is preferred.
• 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%.

Skills

• Downstream process development
• Tech transfer and CDMO interaction
• Process characterization and validation
• Regulatory submissions (IND, IMPD, BLA)
• Quality by Design (QbD) and DoE
• Viral clearance operations
• Cross-functional leadership and stakeholder management

Education

• Degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field (MS/PhD preferred)

Additional Requirements

• Up to 25% travel domestically and internationally