Quality Control Scientist
About The Position
The Quality Control Scientist provides technical expertise to research and develop new, or improve existing analytical processes to evaluate oncolytic viral and viral vector based therapeutics, pipeline assets, and to improve overall efficiency in QC processes towards commercialization. Key responsibilities include performing and supporting analytical testing, method development and validation, and quality control (QC) release activities in compliance with cGMP and regulatory standards. The QC Scientist will work closely with internal teams to ensure the timely release of materials, intermediates, and final products used in various phases of drug pipeline.
Requirements
- Advanced degree (Ph.D. and/or relevant degree highly desirable) and 2+ years of related work experience, or a Bachelor's degree with 5+ years of related work experience
- Minimum of 1 year working in biologics drug product role with a good understanding of working with a defined QMS and assay qualification.
- Experience with setting up, supporting, and troubleshooting multiple pieces of drug product analytical equipment.
- Experience with advanced QC techniques, including qPCR/dPCR, flow cytometry, potency assays, and/or ELISA.
- Experience conducting process characterization, analysis and development with minimal supervision.
- Knowledge of ICH Q2(R2), FDA/EMA regulations for ATMPs, and cGMP testing principles.
- Excellent analytical, documentation, and communication skills.
Responsibilities
- Perform GMP testing of various sample types, which may include raw materials, in-process samples, cell banks, viruses/viral vectors, and final drug products using molecular, biochemical, and/or cell-based analytical methods.
- Execute assays including qPCR/dPCR, flow cytometry, ELISA, infectivity/titer assays, vector genome copy number determination, potency assays, and detection of production contaminants
- Support method development, qualification, validation, and transfer for novel analytical methods specific to various biologic/cell and gene therapy platforms.
- Participate in stability studies, and trending of analytical data to ensure product consistency and compliance.
- Review and interpret analytical data, ensuring data integrity and alignment with specifications, SOPs, and regulatory requirements.
- Support investigations of deviations, OOS/OOT results, and implementation of CAPAs.
- Author, review, and revise controlled documents, including test methods, protocols, reports, and SOPs.
- Collaborate with QA, Manufacturing, Process Development, and Regulatory teams to support product release and regulatory filings (e.g., IND, BLA, IMPD).
- Maintain laboratory equipment and ensure calibration, qualification, and preventive maintenance activities are completed as required.
- Uphold GMP compliance, data integrity, and safety practices in a dynamic, fast-paced environment.
- Additional duties as assigned
Benefits
- Group Healthcare Plan, including company paid dental and vision.
- Short- and long-term disability, life and AD&G insurance.
- Simple IRA with employer match
- Educational assistance program
- Holiday and PTO
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
51-100 employees
