Quality Control Senior Scientist
About The Position
The Quality Control Senior Scientist position is expected to manage a small group of quality control (QC) personnel and provide team oversight in the analytical and technical aspects of QC testing programs supporting oncolytic viral and viral vector-based therapeutics. Other initiatives may include making modifications to existing assays to improve overall efficiency and progress in drug phase pipeline. Key responsibilities include deep technical understanding of the assays, participation in investigations, regulatory support, and mentorship within the QC organization.
Requirements
- Advanced degree (Ph.D. and/or relevant degree highly desirable) and 4+ years of related work experience, or a Bachelor's degree with 9+ years of related work experience
- Minimum of 3 years 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.
- Proven expertise in at least one area of cell-based potency, molecular, and/or biochemical/protein assays.
- 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
- Supervise personnel involved with 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.
- Serve as technical lead for assays which may include qPCR/dPCR, flow cytometry, ELISA, infectivity/titer assays, vector genome copy number determination, potency assays, and detection of contaminants, or coordination for send-out testing.
- Lead initiatives in method development, qualification, validation, and transfer for novel analytical methods specific to various biologic/cell and gene therapy platforms.
- Lead initiatives 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.
- Serve as primary investigator of deviations, OOS/OOT results, and implementation of CAPAs.
- Mentor QC Analysts and Scientists in analytical techniques and GMP practices
- 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
