- Responsibilities:Perform rigorous quality control testing and analysis of gene therapy products, including viral vectors, plasmids, in accordance with established protocols and regulatory requirements.
- Conduct visual inspections and assessments of product integrity, purity, and potency using advanced analytical techniques and instrumentation.
- Execute a variety of assays, such as ddPCR, ELISA, capillary electrophoresis, HPLC to assess product quality attributes and ensure consistency across batches.
- Maintain detailed documentation of all quality control activities, including test results, deviations, and corrective actions, in compliance with regulatory guidelines and company procedures.
- Collaborate closely with cross-functional teams, including Research and Development, Manufacturing, and Quality Assurance, to troubleshoot issues, investigate root causes of quality deviations, and implement effective corrective and preventive actions.
- Assist in the development and optimization of new analytical methods and procedures to improve efficiency, accuracy, and throughput in the quality control laboratory.
- Support internal and external audits, inspections, and regulatory submissions by providing accurate and timely documentation and data analysis.
- Top Requirements: BS degree minimum
- Minimum of 1-2 year of experience in quality control, quality assurance, or a related role, preferably in a regulated industry
- Strong attention to detail and excellent analytical skills.
- Proficiency in conducting various quality control tests and inspections.
- Familiarity with quality management systems and regulatory requirements (e.g., ISO standards, FDA regulations) is preferred.
- Ability to work effectively both independently and as part of a team.
- Excellent communication skills, both written and verbal.
- Highly organized with the ability to prioritize tasks and meet deadlines.
- Proficiency in Microsoft Office applications and other relevant software tools.
Lab Research Associate - San Diego, United States - Redbock - an NES Fircroft company
Description
A fast-growing Biotechnology company focused on developing gene therapy products is in immediate need of two Research Associates for a 6-month project that needs to be completed while working onsite in San Diego. The Research Associates will primarily be responsible for the preparation of the buffer and reagent preparation, Capillary electrophoresis, droplet digital PCR, culture of primary mammalian cells, and cell-based potency assays. The role will perform routine laboratory maintenance tasks as well as execute various analytical procedures to support lot release and stability testing of samples for clinical phase gene therapy products.
The Research Associates will be supporting the client's QC Lab in San Diego, the specialists will be focused on administrative support for buffer preparation and he or she will also support release and stability testing as well as inventory management, and calibration and maintenance schedules. The specialists will be working in a large state-of-the-art lab that typically has 5-7 people working in it at once time. Any experience with or knowledge of gene therapy will be valuable for these roles. The team is highly collaborative and is growing quickly, making this a great opportunity for someone who is passionate about life sciences and has some assay development and testing experience.