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QC Manager

QC Manager

ActalentMadison, WI, US
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Qc Manager

We are seeking a proactive and detail-driven Quality Control (QC) Manager to oversee day-to-day QC operations and ensure consistent execution of GMP-compliant testing for our iPSC-derived neuronal cell therapy programs. This role is ideal for someone with strong technical acumen and people management skills who thrives in a fast-paced, early-stage biotech environment and is eager to grow with the organization.

Responsibilities

  • Maintain a comprehensive inventory of completed activities across manufacturing and quality functions at both sites, with a strong emphasis on accurate tracking.
  • Lead problem-solving efforts for any issues or deviations that arise during operations.
  • Conduct root cause analyses and recommend strategic solutions to address underlying problems.
  • Review protocols provided by the San Diego site and oversee sample running in accordance with those protocols (ddPCR, ELISA, flow cytometry).
  • Prepare and document CAPA reports.
  • Apply knowledge of regulatory standards, with a preference for familiarity with GMP (Good Manufacturing Practices).
  • Collaborate on projects involving stem cells.

Essential Skills

  • Bachelor's Degree in Cell Biology, Molecular Biology, Biotechnology, or a related discipline.
  • Cell therapy experience is very ideal, but not required.
  • Minimum of 3+ years of experience in a QC GMP (ideally cGMP) environment in QC Leadership.
  • Must have minimum of 1 year experience, ideally 2 years in flow cytometry, ddPCR, and ELISA.
  • Familiarity with phase-appropriate QC systems and regulatory expectations (FDA / EMA, ICH guidelines).
  • Experience with CAPAs and writing CAPA reports.
  • Experience troubleshooting.
  • Previous leadership and management skills.

    • Work Environment

    The company is a growing biotechnology organization that provides high-purity, iPSC-derived human neurons, astrocytes, and microglia for translational research and drug discovery. Utilizing proprietary technology, they generate a variety of assay-ready, subtype-specific cells of the CNS, relevant to a range of neurological disorders. Each cell subtype can be produced from unique iPSC lines into custom batches ranging from 50 million to 10 billion viable cells. The work environment is vibrant and collaborative, fostering a space where talented individuals can thrive and make a meaningful impact. The team currently consists of 5-6 individuals, with plans for expansion once the QC Manager is hired. The manager will have the opportunity to influence the hiring and building of this team. The company is in the process of building a whole GMP lab, offering the new manager control and the chance to be part of something great in the future.

    Pay and Benefits

    The pay range for this position is $100000.00 - $125000.00 / yr.

    Medical, dental, vision, bonus

    Workplace Type

    This is a fully onsite position in Madison,WI.

    Application Deadline

    This position is anticipated to close on Oct 10, 2025.

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    Qc Manager • Madison, WI, US