Specialist, Quality Control Analytical
Role Overview
Provide analytical testing support for fusion proteins, cell therapies, and cancer vaccine programs.
Work includes wet chemistry, chromatography, spectroscopy, and ELISA, as well as testing, method development, optimization, and investigations.
Key Skills for This Role
Full Job Posting
Position summary
Provide analytical testing support for fusion proteins, cell therapies, and cancer vaccine programs.
Work includes wet chemistry, chromatography, spectroscopy, and ELISA, as well as testing, method development, optimization, and investigations.
Essential functions
- Provide in-process and suitability-for-use testing support.
- Support method development, optimization, and investigational studies.
- Create testing protocols and reports.
- Perform laboratory maintenance and support, including required records and deliverables.
- Complete change controls, SOPs, test method updates, and related quality-system documentation.
- Perform assigned cross-functional duties and projects.
- Conduct complex troubleshooting and investigations.
Education and experience
- Bachelor’s degree in Biochemistry or a related discipline with 4 or more years of biotechnology-industry experience, or a master’s degree in a related discipline with 2 or more years of such experience.
- Experience working in a cGMP laboratory is required.
- Hands-on HPLC and ELISA experience is preferred.
Knowledge and abilities
- Working knowledge of QC testing requirements, methodology, and equipment such as pH meters and analytical balances.
- Knowledge of cGMP, FDA, and USP regulations and basic statistics.
- Strong interpersonal, communication, organizational, and problem-solving skills.
- Ability to manage priorities in a fast-paced team environment.
- Knowledge of MS Word and Excel.
Work environment
- The position works onsite in Dunkirk, New York, in an in-laboratory environment.
- Schedule flexibility, including off-hours, may be needed.
Pay
- Hourly base pay ranges from $33.65 to $37.00 depending on qualifications, experience, and geographic location.
- The position is eligible for a discretionary bonus and equity award.
Benefits
- Eligible benefits include medical, dental, and vision plans; wellness programs; EAP; life and disability coverage; flexible spending accounts; a 401(k) plan with company match; and paid time off.
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