Quality Control Scientist

Benefits

Pulled from the full job description

Full job description

Trailhead Biosystems is seeking a Quality Control Scientist with deep expertise in iPSC biology and quality control. This role blends hands-on laboratory work with quality oversight, focusing on the development of QC parameters, release specifications, and Certificates of Analysis (CoAs) for iPSC and iPSC-derived cell products.

This role will be responsible for defining and implementing analytical methods and QC frameworks that ensure reproducibility, traceability, and scientific rigor across Trailhead’s RUO product portfolio.

Responsibilities

Assay Transfer & QC Release

• Lead the transfer of analytical methods from R&D into QC, establishing SOPs, acceptance criteria, and qualification data for each method.
• Own QC release testing for iPSC and iPSC-derived cell products, including in-process controls, final product release, stability studies, and comparability testing.
• Define critical quality attributes (CQAs), release specifications, and Certificates of Analysis (CoAs) for differentiated cell types.
• Execute and troubleshoot cell-based assays: flow cytometry, ICC/IF, qPCR, ELISA, viability, potency, and functional assays.
• Establish and maintain standardized QC panels for pluripotency markers, genomic stability, and differentiation identity and purity.

Analytical Method Development

• Develop, optimize, and qualify analytical methods for cell characterization and product release.
• Evaluate new assays to support characterization of novel iPSC-derived product programs.
• Partner with R&D and MSAT to define in-process QC checkpoints, acceptance criteria, and critical process parameters across iPSC derivation, expansion, banking, and differentiation workflows.
• Ensure methods are robust, reproducible, and transferable across operators and runs.

Quality System Contribution

Quality system work is secondary to hands-on QC execution in the near term. This role contributes to the QMS buildout scoped to QC-relevant elements.

• Author and maintain QC-specific SOPs, test methods, QC protocols, and data integrity practices.
• Participate in deviation investigations and CAPA activities related to QC operations.
• Support ISO 9001/13485 readiness as it pertains to QC functions.
• Track and report QC metrics to inform operational decisions and identify improvement opportunities.

Training & Team Development

• Train R&D, MSAT, and manufacturing staff on QC assays, data documentation, and quality principles.
• Serve as the internal subject matter expert on iPSC-relevant QC assays and release frameworks.

Qualifications

• MS + 5 years or PhD + 2 years of hands-on experience in QC or analytical development, with at least 1 year in a formal QC role for cell-based products.
• Demonstrated experience transferring assays from R&D into QC, including establishing SOPs, acceptance criteria, and qualification data.
• Proficiency with iPSC-relevant assays: flow cytometry, ICC/IF, qPCR, viability, and functional or potency assays.
• Degree in Cell Biology, Stem Cell Biology, Molecular Biology, or a closely related field.
• Experience defining release specifications, CQAs, and CoAs for iPSC or iPSC-derived cell products.
• Working knowledge of ISO 9001 or ISO 13485 quality standards.
• Experience supporting quality system functions — deviations, CAPA, investigations — in an RUO or preclinical environment.
• Ability to work independently and thrive in a fast-paced, hands-on environment where systems are still being built.

Preferred

• Direct hands-on experience with iPSC derivation, expansion, and/or differentiation Experience in an early-stage or startup environment where you built QC systems rather than inherited them.
• Familiarity with in-process QC integration into manufacturing or MSAT workflows.
• Experience authoring or reviewing SOPs, QC protocols, and quality records.
• Background in cell therapy, regenerative medicine, or iPSC-derived product commercialization.

Job Type: Full-time

Pay: $90,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Relocation assistance
• Vision insurance

Application Question(s):

• Will you now or in the future require sponsorship for employment visa status (e.g., H-1B, O-1, etc.)?

Ability to Commute:

• Beachwood, OH 44122 (Required)

Ability to Relocate:

• Beachwood, OH 44122: Relocate before starting work (Preferred)

Work Location: In person