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Scientist I – CMC Technical Operations

Location: Massachusetts - Hybrid

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:

The Scientist-1, CMC Technical Operations, will develop and manufacture pharmaceutical formulations for small molecules and establish suitable analytical methods to support clinical-stage programs and commercialization.

RESPONSIBILITIES:

  • Analyze and curate experimental designs or Design of Experiments (DoE) to improve robustness, efficiency, accuracy and repeatability of methods such as assay and related substance (ARS), particle size distribution (PSD), dissolution etc.
  • Manage and oversee stability programs for clinical and commercial products, ensuring compliance with ICH, FDA, EMA, USP, and Ph. Eur. guidelines.
    • Design reviewing stability protocols for Phase III and Registration phase
    • Maintain incoming Laboratory Information Management Systems (LIMS) data
    • Ensure the traceability and integrity of incoming raw data to support regulatory and quality standards.
  • Optimize chromatographic methods (e.g., HPLC, GC) and provide scientific direction to evaluate errors in analytical instrument calibration, raw material variability, moisture content variability, operator errors, packaging failure etc.
  • Analyze, interpret and trend analytical, release/ stability data for small molecule drugs from active stability programs and present findings in the internal team meetings.
  • Direct, coordinate and oversee vendor /CDMO operations, including manufacturing, scale-up, process development, technology transfer, and execution of laboratory experimental studies, based on the internal timelines and activities.
  • Coordinate troubleshooting activities at the vendor/CDMO site for technical challenges during drug manufacturing or testing, such as out-of-specification (OOS) and out-of-trend (OOT) results.
  • Identify, implement and negotiate effective resolutions with appropriate CAPA in place in partnership with Quality Assurance team.
  • Monitor, draft, and review GMP compliant analytical test methods, stability protocols, validation protocols, and experimental reports.
  • Utilize understanding of a range of analytical techniques (which include liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS)/ high pressure liquid chromatographs (HPLC)) to conduct research and development studies related to small-molecule active pharmaceutical ingredients, intermediates, starting materials, impurities along with pre-clinical to clinical formulations.
  • Evaluate GMP batch records, deviation investigations, and technical reports to ensure strict adherence to scientific and FDA, EMA and other regulatory standards.
  • Coordinate and contribute to all levels of product development i.e. Phase I, II, III/ Registration/ NDA of product development.
  • Perform continuous research and trend the drug substance and tablet manufacturing batches for assay, impurities, water content etc. profiles on stability, to set specifications/ standards for continuous manufacturing of drug product.
  • Coordinate small molecule drug activities at the CDMO site with scientists specializing in manufacturing operations and analytical chemistry functions, ensuring alignment with internal stakeholders.
  • Monitor and critically assess the progress of vendor/CDMO activities, ensuring strict adherence to project timelines, budgetary/financial constraints, and quality standards while maintaining detailed and accurate scientific records.
  • Facilitate technology transfer activities, ensuring comprehensive documentation and knowledge transfer between internal teams and vendors/CDMOs.
  • Author CMC-related sections in regulatory filings (FDA, EMA etc. documents) by reviewing documentation and ensuring accuracy and completeness.
  • Design and implement experimental workflows in collaboration with CDMO to facilitate efficient data management (e.g. raw materials, impurities/markers, reference standard, raw analytical data) for manufacturing and research, ensuring traceability and operability across laboratory and production environments.
  • Assess the scale-up equipment and newly implemented test procedures with the vendors to meet the product, quality, and regulatory requirements at clinical/commercial stage of the program.
  • Travel to vendor sites in Ohio, South Carolina and Oregon.
  • May work remotely up to two days per week.

 REQUIREMENTS:

  • Master’s degree in microbiology, biology, biotechnology, chemistry or a related field.
  • Demonstrated proficiency with purification and characterization studies.
  • Demonstrated proficiency in planning and executing experiments independently without routine supervision.
  • Demonstrated proficiency in interpreting data and presenting to cross-functional teams.
  • 25% travel to vendor sites in Ohio, South Carolina and Oregon

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 careers@discmedicine.com.

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