The primary purpose of the research associate position is to perform complex, highly specialized and time sensitive technical cell manipulation and testing procedures on irreplaceable cellular products in a current Good Manufacturing Practice (cGMP) facility as well as perform experiments pertaining to process, product, or assay development.
RESEARCH ASSOCIATE - CMC
- Perform cell growth and manipulation procedures such as cell enrichment, cell evaluation and sorting, cell culture, cellular product cryopreservation, cell product thaw/wash.
- Perform error free calculations to determine cell viability, dilutions, and cell concentrations.
- Perform procedures and maintain accurate documentation in compliance with FDA’s Good Laboratory Practices, Good Manufacturing Practices, Good Tissue practices, as well as standards set by other accreditation agencies including but not limited to FACT, CAP, and CLIA. Document deviations and events, notify supervisor and quality management personnel in timely manner and assist in investigation of cause and any required corrective actions.
- Perform cell-based studies or assays for product development, assay development, or product characterization.
- Responsible for aseptic handling of reagents and products to ensure the integrity and sterility of cellular products until final infusion to the patient. Must adhere to special cleaning and gowning requirements for the facility requiring specialized gowning such as masks, sterile jumpsuits, hair and shoe covers.
- Maintain knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
- Perform quality control testing, routine equipment maintenance and troubleshooting.
- Perform and handle human peripheral blood for processing and product manufacture.
- Coordinate and manage supply inventory.
- Work closely and collaborate effectively with other departments
- Act as a liaison between process development and GMP manufacturing units within the CMC department.
- Other duties as assigned.
Qualifications and Requirements
To be considered for this position, applicants must meet the following requirements:
- BA/BS/MA in biological sciences or related discipline with a minimum of 1-3 years work-related experience.
- Basic knowledge of primary cell culture and aseptic handling of cultures. Experience in clinical cell processing and equipment operation including but not limited to cell separation devices, automated cell counters, flow cytometers, and FACS sorters.
- PREFERRED: Experience with growing T-lymphocytes or dendritic cells. Industry experience related to process development, scale up, or manufacturing. Experience in conducting molecular and immunological assays (qPCR, FACS, ELISA)
Other Skills and Abilities
- Ability to make sound decisions and approach problems with curiosity and open-mindedness.
- High degree of independent working, analytical reasoning and the ability to communicate effectively.
- Careful editing and documenting your results. Y
- Ability to embrace rapidly changing requirements with an open mind and show a high degree of flexibility in an environment which is marked by a constant striving for excellence.
- Dedication to innovation and science.
- Ability to approach tasks in a structured, reliable and foresighted manner; combined with a high level of individual responsibility, enthusiasm and strong social skills.
Immatics US, Inc. is a highly innovative biopharmaceutical company headquartered in Houston, TX (USA) and co-launched, together with MD Anderson Cancer Center, as a subsidiary of Immatics Biotechnologies GmbH, headquartered in Germany. We are a clinical-stage biopharmaceutical company active in the discovery and development of T-cell redirecting immunotherapies for the treatment of cancer.
Our transformative product candidates are - best in class - Adoptive Cell Therapies and Bispecific TCR molecules. These products are directed against tumor targets that have been identified and validated by Immatics' proprietary and world-leading XPRESIDENT® technology.
Our mission is to bring the power of T-cell redirecting immunotherapies to cancer patients with more than 100 targets covering 20 major solid and liquid tumors with 80% of the discovered targets being novel. We have 2 proprietary technology platforms and 8 proprietary development programs, with 2 in the clinical trial phase as of 2017.
The US has a team of over 40 highly qualified research, medical and business professionals and we are looking for team members who constantly strive for excellence and whose motivation is driven by their dedication to innovation and science.