Specialist, Quality Control Analytical, Dunkirk/Buffalo NY

Position Summary: Specialist, Quality Control Analytical provides QC testing support for fusion proteins, cell therapies, and cancer vaccines, including wet chemistry, chromatography (HPLC, capillary electrophoresis), spectroscopy (UV-Vis), and ELISA. Supports in-process and suitability-for-use testing, method development/optimizations, and investigational studies; performs complex troubleshooting and investigations.

Essential Functions:
- Perform in-process and suitability-for-use testing
- Support method development, optimizations, and investigational studies
- Create testing protocols and reports
- Complete lab maintenance and lab support records/deliverables
- Support quality systems/documentation (change controls, SOPs, test method updates)
- Perform ad-hoc/cross-functional duties and projects to support business needs

Qualifications:
- Bachelor’s in Biochemistry (or related) + 4+ years biotech experience; or Master’s + 2+ years biotech experience
- cGMP laboratory experience (required)
- Hands-on HPLC and ELISA experience (preferred)

Knowledge/Skills:
- QC testing knowledge; pH meter/analytical balance
- cGMP, FDA, USP regulations; basic statistics understanding
- Strong communication/organizational/problem-solving; manage multiple priorities
- Proficient MS Word and Excel

Work Environment:
- On-site in Dunkirk, NY; flexibility for off-hours

Pay/Benefits/Application:
- Discretionary bonus and equity; $33.65–$37.00/hour
- Application window: closes ~60 days from posting (or sooner)
- Relocation assistance for eligible candidates
- Benefits (eligible): Medical/Dental/Vision, EAP, life/AD&D, short/long-term disability, FSAs, 401(k) match, 529, PTO (11 holidays; unlimited PTO for exempt; defined vacation/health pay for non-exempt).