Director, Cell Line and Upstream Process Development

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.

COMPANY OVERVIEW:

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.

POSITION OVERVIEW:

Disc Medicine is hiring a new Director, Cell Line and Upstream Process Development due to the fast growth of the company's portfolio. The successful candidate will serve as the functional lead for both Cell Line Development and Upstream Process Development for Disc Medicine's biologics program pipeline, including early and late-stage development through Process Characterization and Process Performance Qualification (PPQ). Reporting to the Vice President of Biologics Drug Substance Development within the Technical Operations function, this position will have visibility to strategic decision-making bodies such as the CMC teams and program teams, with meaningful opportunities for professional development and career growth.

RESPONSIBILITIES:

• Spearhead late-stage development for upstream processes, including CQA assessment, Process Lifecycle Risk Assessment (PLRA), and design Scale-Down Model Verification (SDMV) and Process Characterization (PC) campaigns for late-stage upstream processes. Utilize statistical tools like Design-of-Experiments (DoE) methodologies to identify critical process parameters and delineate their effects on Critical Quality Attributes (CQAs) to derive and formulate a comprehensive Process Control Strategy (PCS). Review and approve comprehensive documentation, including SDMV and PC reports.
• Lead upstream process validation strategy, with associated documentation (risk assessments, validation master plan, validation protocols) and guide programs through successful Process Performance Qualification (PPQ).
• Function as key SME resource in the preparation of regulator documents. Author and review Module 3 sections for regulatory filings and interactions, including preparation of original INDs, IND amendments, Type C meetings, and BLA.
• Critically evaluate different drug substance CDMOs and service providers for Cell Line Development with regards to expression technology, monoclonality, productivity and product quality, as well as bioreactor capacity and scale-up capability.
• Support negotiations on associated Master Service Agreements (MSA), contracts, Scopes of Work (SOWs), and manage Change Orders.
• Oversee external operations for Cell Line Development and Upstream manufacturing, and author, review or approve associated source documents.
• Function as Person-in-Plant for both early and late-stage Upstream manufacturing campaigns.
• Lead early-stage upstream development efforts at various CDMOs, and design seed train strategies and bioreactor fed-batch processes for the generation of tox material and Phase 1 clinical material.
• Review and approve technical development reports, GMP batch documentation, manufacturing campaign summary reports, associated change controls, deviations, and other quality documents as technical subject matter expert (SME).
• Function as SME on CMC teams and program teams for all biologics programs, and report progress to senior leadership through different governance bodies. Present scientific data both internally and externally at conferences.
  
  

REQUIREMENTS:

• PhD in biology, biochemistry, or biological or mechanical engineering, or a related discipline
• Minimum 10 years of industry experience in applicable roles
• Experience designing Scale-Down Model Verification and Process Characterization campaigns is a must; experience in late-stage development, overseeing manufacturing of pivotal material, and successful process validation (PPQ) is also required.
• Deep experience with statistical software tools such as JMP, and managerial experience leading staff is desired.
  

Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.

Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.