A Quality Control Chemist uses chemistry analysis to test samples of manufacturing or pharmaceutical products, to ensure that products meet quality standards.
Vyriad is an early stage biotechnology company focused on curing cancer using potent, safe and cost-effective cancer therapies utilizing engineered replication competent viruses designed to selectively and rapidly destroy cancer. Revolutionizing cancer treatment is our long-term goal, requiring curiosity, perseverance, an openness to challenging convention and a commitment to excellence. The challenges are complex, the work pace is fast, and progress is seldom a straight line. All of this makes for an exhilarating environment of collaboration, discovery and fun.
GENERAL JOB DESCRIPTION
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.
SUPERVISORY RESPONSIBILITIES
No
DUTIES AND RESPONSIBILITIES
Method Development and Product Testing 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
EDUCATION AND EXPERIENCE 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.
PHYSICAL REQUIREMENTS
Prolonged periods of standing at laboratory benches. Prolonged periods of sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times
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 Job Type:
Full-time Pay:
$78,000.00 - $102,000.00 per year
Benefits:
Dental insurance Employee assistance program Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Parental leave Relocation assistance Retirement plan Tuition reimbursement Vision insurance
Education:
Bachelor's (Required)
Experience:
Quality control: 2 years (Required) Ability to
Relocate:
Rochester, MN 55901: Relocate before starting work (Required)
