Associate Director, Upstream Biologics Drug Substance jobs in United States
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Disc Medicine · 2 months ago

Associate Director, Upstream Biologics Drug Substance

positionMassachusetts - Hybrid
timeFull-time
remoteHybrid
senioritySenior Level, Lead/Staff, Director/Executive
money$157K/yr - $213K/yr
date8+ years exp

Disc Medicine is a clinical-stage biopharmaceutical company focused on developing novel treatments for serious hematologic diseases. The Associate Director, Upstream Biologics Drug Substance will lead the design, optimization, and scale-up of upstream processes for biologic programs, ensuring product quality and compliance with regulatory standards.

BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
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H1B Sponsor Likelynote

Responsibilities

Lead upstream process development for biologic programs from preclinical through late-stage development, ensuring scalability, robustness, and product quality
Oversee cell line development, media/feed optimization, bioreactor scale-up, and process parameter definition
Lead tech transfer to CDMO manufacturing sites, ensuring successful execution at pilot and large scale
Design and direct studies for process characterization, process performance qualification (PPQ), and technology transfer
Author and review key development reports, risk assessments, and regulatory submission documents (IND, IMPD, BLA)
Partner with analytical, downstream, and manufacturing sciences teams 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)
Lead troubleshooting and deviation investigations for upstream operations
Contribute to defining process control strategies and lifecycle management plans in alignment with relevant guidelines
Foster technical excellence and innovation within the upstream development 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

Upstream process developmentMonoclonal antibodiesCell culture systemsProcess scale-upTech transferRegulatory filingsLeadership skillsCommunication skillsCollaboration skillsProblem-solving skills

Required

A degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related discipline with 8+ years of relevant industry experience
Proven track record in upstream development and manufacturing of monoclonal antibodies, including both early (Phase 1/2) and late-stage (Phase 3/commercial) programs
Hands-on experience with mammalian cell culture systems (CHO, NS0, etc.), fed-batch and/or perfusion processes
Strong understanding of process scale-up, tech transfer, and process validation principles
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
Flexible work environment

Company

Disc Medicine

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Disc Medicine is a biopharmaceutical company that develops therapies for hematologic diseases and rare blood disorders.
dateFounded in 2017
location
Watertown, Massachusetts, USA
people-size51-200 employees
web-link
https://www.discmedicine.com

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 Company
Total Funding
$1.29B
Key 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

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Jean Franchi
Chief Financial Officer
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Jonathan Yu
Chief Operating Officer
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Recent News

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2026-01-07
Boston Globe
A new drug has allowed two women to go in the sun for the first time. They’re terrified they may have to give it up.
2025-12-29
BioSpace
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2025-12-22
Company data provided by crunchbase