Histology Technologist PATDC

• Primarily focused on scientific writing and pathology slide grading/review.
• Responsible for grading pathology slides and completing associated documentation.
• Supports testing activities and requires microscope proficiency.
• Strong pathology knowledge preferred.
• Limited hands-on laboratory work; will work closely alongside laboratory teams.
• Strong scientific and technical writing skills are critical.
• Candidates from pharmaceutical, clinical, pathology, or related scientific backgrounds may be applicable.
• MDR (Medical Device Regulation) experience is relevant and transferable.
• Regulatory experience preferred, including ICH and tissue morphology-related work.

Candidate Profile

• Preferred education:
  
  PhD or MD.
• Will consider candidates with a bachelor’s or master’s degree and strong relevant experience.
• Looking for a highly intelligent, trainable candidate who can learn quickly.
• Must be comfortable with scientific documentation, slide interpretation, and regulatory-focused work.

The Ideal Candidate will have:

• Bachelor's or Master's degree in biochemistry, molecular biology, immunology, oncology, pathology, histotechnology, life sciences, or a related scientific field, with relevant industrial, academic, or clinical laboratory experience. A Ph.D. and/or M.D. in a relevant field is preferred but not required.
• Experience with IVD products, IHC, scientific or clinical literature evaluation, EU IVDR performance evaluation, PMS/PMPF, and scientific or medical writing is preferred. Certification as a Histotechnologist or other relevant certification by the ASCP is a plus.
• Strong scientific and technical writing skills with the ability to prepare clear, well-supported, and understandable documentation.
• Ability to critically evaluate scientific literature, clinical evidence, analytical and clinical performance data, and post-market information.
• Working knowledge of EU IVDR performance evaluation, PMS, and PMPF concepts and documentation; understanding of ISO 13485, applicable quality system requirements, and GMP principles.
• Strong knowledge of IHC and staining interpretation, with the ability to consistently grade slides and communicate scientifically sound conclusions.
• Ability to analyze experimental and post-market data, identify trends or gaps, and translate findings into appropriate scientific documentation and follow-up activities.
• Adheres to SOPs, quality standards, continual improvement principles, and applicable root cause analysis activities.