Disc Medicine · 2 months ago
Associate Director, Downstream Biologics Drug Substance
Massachusetts - Hybrid
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$157K/yr - $213K/yr
8+ years expDisc Medicine is a clinical-stage biopharmaceutical company focused on developing innovative treatments for hematologic diseases. The Associate Director of Downstream Biologics Drug Substance will lead the design and optimization of downstream processes, ensuring scalability and product quality throughout development stages.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
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 investigation, CAPAs and process improvement initiatives
Provide technical oversight for viral clearance studies and ensure alignment with regulatory expectation
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 — 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, as appropriate, to proactively identify technical risks and provide scientific recommendations for mitigation plans
Contribute to a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement
Qualification
Required
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%
Preferred
MS or PhD is preferred
Benefits
Comprehensive benefits
Competitive compensation packages
Company
Disc Medicine
Disc Medicine is a biopharmaceutical company that develops therapies for hematologic diseases and rare blood disorders.
51-200 employees
H1B Sponsorship
Disc Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.29BKey Investors
Hercules CapitalFrazier Life SciencesBain Capital Life Sciences
2025-10-21Post Ipo Secondary· $25M
2025-10-21Post Ipo Equity· $225M
2025-01-22Post Ipo Equity· $225.5M
Leadership Team
Jean Franchi
Chief Financial Officer
Jonathan Yu
Chief Operating Officer
Recent News
2026-01-13
2026-01-13
Company data provided by crunchbase