Lead Consultant (Histology)

Job Title : Lead Consultant (Histology) Initial 12 Month Contract Fully on site, Kalamazoo, Michigan Very competitive hourly rate (W2) + all expenses covered Multi year project Role Overview: This role focuses on stabilising and optimising a long-standing, regulated animal-based histology assay used in the manufacture of a globally supplied, lifesaving biologic for a rare disease.

The assay has been in place for over 50 years and is now experiencing increased variability and batch failures, impacting control, efficiency, and throughput.

Project Phases & Responsibilities: Phase 1: Assay Stabilisation & Control: Lead investigation into assay variability and validation challengesConduct detailed root cause analysis to identify sources of inconsistencyRegain control, reliability, and robustness of the existing methodStrengthen oversight and reduce batch failures Phase 2: Optimisation & Improvement Refine and optimise the assay to improve performance and efficiencyIdentify opportunities to modernise elements of the process while maintaining regulatory complianceIncrease throughput and reduce variability Phase 3: Knowledge Transfer & Sustainability Embed improvements into standard practiceEnsure reproducibility and long-term method stabilityProvide documentation updates, training, and periodic review processes This position requires strong pharmaceutical manufacturing experience, deep expertise in histology, and a hands-on, investigative mindset to troubleshoot and enhance a critical legacy assay in partnership with laboratory and cross-functional teams.