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Scientist, Analytical Sciences
Durham, NC 27713 United States
801 Capitola Drive, Suite
We offer a competitive compensation and benefits package as well as an environment where your contributions can make a significant difference
Research and Development
Heat Biologics is a public biotechnology company focused on the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to eradicate cancer cells. We believe our immunotherapy is a market-redefining approach to the treatment of cancer. We are an innovative and growing company and have a highly energized and accomplished team.
We are seeking a highly motivated individual for the role of Analytical Scientist. The position will be based in Durham, North Carolina and will directly report to the Director of Analytical Sciences in the CMC function. The Scientist works with the Analytical Sciences team to define and implement the analytical strategy to support the development of Heat Biologics’ products.
The Scientist will primarily be involved in the development of the analytical methods to be used for QC release and stability testing of cGMP material. It is expected that up to 75% of the Scientist’s time will be spent in the laboratory. The Scientist will also support technology transfer of analytical activities to contractors (e.g. CDMOs, third-party vendors) and help with the management and supervision of external activities (e.g. verification, qualification, validation). The Scientist may also be involved in process and product characterization activities as well as provide analytical support for R&D and pre-clinical activities.
A successful candidate must be organized, self-motivated, and able to thrive in a fast-paced dynamic biotech environment where flexibility, tolerability to rapid change, and drive to make a significant impact is essential.
• Development of analytical methods to support QC release and stability testing as well as characterization of Heat Biologics’ cell therapy products.
• Author the analytical and quality documentation as needed (protocols, development reports, SOPs).
• Support technology transfer of analytical activities to contractors (CDMOs and third-party vendors).
• Help with the management and supervision of external activities (e.g. verification, qualification, validation).
• Support review of cGMP manufacturing analytical data for in-process, release testing and stability studies.
• Involved in review and management of quality events (e.g. deviations, OOS/OOT analysis and investigations).
• Perform routine testing as needed and conduct characterization studies to support process and product development activities.
• Performs other work-related duties as assigned.
• On-site oversight of the activities at the contract manufacturers may be required. This position may require domestic and/or international travel (up to 10%).
• Bachelor’s or Master’s degree required in a related scientific field (biology, immunology, or biochemistry preferred).
• 3+year experience in the Biotech and/or Biopharmaceutical industry. Analytical development or QC experience required.
• Experience with the all the following analytical methods highly desirable: ELISA, cell counting, flow cytometry, RT-PCR. Gel electrophoresis, Western blotting.
• Experience with mammalian cell culture and good aseptic technique preferred.
• Good working knowledge of GMP.
• Good written and verbal communication and interpersonal communication skills to effectively interact with all levels both within and outside the company.
North Carolina Biotechnology Center