CMC Manager, Drug Substance

5 hours ago

Waltham, Massachusetts, United States Upstream Bio Full time
Job Summary

We are seeking a highly skilled CMC Manager to join our team at Upstream Bio. As a key member of our organization, you will be responsible for providing strategic oversight of external contract development and manufacturing organizations (CDMOs) to ensure timely delivery of drug substance and drug product.

Key Responsibilities
  • Oversee CDMO relationships to ensure compliance with cGMP standards and timely delivery of drug material.
  • Review and approve CDMO documentation, including batch records, protocols, and reports.
  • Monitor and evaluate analytical in-process, release, and stability testing results.
  • Manage deviations, including manufacturing investigations and OOS/OOT results.
  • Collaborate with quality and regulatory teams to ensure drug material meets cGMP standards.
  • Coordinate domestic and international drug material shipments.
  • Supervise process characterization and validation, and tech transfers as needed between contract sites.
  • Utilize knowledge of impact assessment and risk mitigation to contribute to technical operations strategy.
  • Support the filing of documents, including reviewing manufacturing sections of IMPD/IND or related regulatory dossiers, and authoring responses to regulatory questions in partnership with Regulatory CMC.
  • Assist in inspections of contract testing and manufacturing sites.
Requirements
  • Bachelor's degree in engineering, life sciences, or related field. Advanced degree encouraged but not required.
  • A minimum of 5 years of experience in biopharmaceutical/pharmaceutical industry, preferably with experience in monoclonal antibody manufacturing.
  • Ideally 3+ years of experience managing CDMOs/third parties for cGMP manufacturing and testing.
  • Detailed knowledge of ICH guidelines, current Good Manufacturing Practices (cGMP), and compendial (USP, EP, JP, etc.) requirements and standards for QC testing.
  • Knowledge of biotechnology/pharmaceutical product development process, including technical transfer, manufacturing, process development and characterization, analytical/assay development, regulatory filings, and clinical/commercial operations.
  • Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Visio, Outlook). Experience with other PM tools a plus (e.g. ThinkCell, OnePager, Kidasa, Smartsheets etc.).
  • Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
  • Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
  • Ability to work effectively as an individual contributor in a global team, collaborate with external partners/CDMOs to complete projects and adjust priorities as required to meet evolving company needs and deadlines.
About Upstream Bio

Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitug's unique attributes to address the substantial unmet needs for patients underserved by today's standard of care. Learn more about us at upstreambio.com.

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