Specialist, Quality Control Analytical

Position Summary

The Specialist, Quality Control Analytical will provide testing support for various programs (fusion proteins, cell therapies and cancer vaccines), which can include but is not limited to, wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA. The position will be responsible for providing testing support through In Process testing, and suitability for use testing, method development, optimizations, and investigational studies. The Specialist will undertake complex troubleshooting and investigations.

Essential Functions

• Provides testing support through In Process, and suitability for use testing
• Provides support for method development, optimizations and investigational studies.
• Creates testing protocols and reports
• Performs lab maintenance and lab support Functions including completing maintenance records and deliverables
• Provides quality systems and documentation support and completes change controls, standard operating procedures (SOPs) and test method updates, and associated documents
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Education & Experience

• Bachelor’s degree in Biochemistry or related discipline with 4+ years of experience in the Biotechnology industry required; or
• Master’s degree in Biochemistry or related discipline with 2+ years of experience in the Biotechnology industry required
• Hands-on experience with HPLC and ELISA preferred
• Must have experience working in cGMP laboratory

Knowledge, Skills, & Abilities

• Strong interpersonal, communication, organizational, and problem-solving skills
• Working knowledge of QC testing requirements, methodology, and general equipment such as pH meter and analytical balance
• Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
• Ability to be flexible and manage multiple priorities in a fast-paced environment
• Ability to thrive in an efficient, highly interactive, goal-oriented team environment
• Knowledge of MS Word and Excel

Working Environment / Physical Environment

• This position works on site in Dunkirk, NY
• Flexibility in working schedule, i.e., off-hours
• Exposure to onsite in-lab environment