The Research Associateposition will 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.
- Performs cell growth and manipulation procedures such as cell enrichment, cell evaluation and sorting, cell culture, cellular product cryopreservation, cell product thaw/wash.
- Perform cell-based studies or assays for product development, assay development, or product characterization.
- Performs error free calculations to determine cell viability, dilutions, and cell concentrations.
- Performs 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. Records deviations and events, notifies supervisor and quality management personnel in timely manner and assist in investigation of cause and any required corrective actions.
- 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.
- Performs procedures and maintains accurate documentation in compliance with Standard Operating Procedures and appropriate federal and local regulations.
- Follows procedures and policies implemented by the organization and adheres to all defined process and documentation requirements.
- Maintains knowledge regarding donor evaluation, screening and testing, labeling and product acceptability and release criteria.
- Performs quality control testing, routine equipment maintenance and troubleshooting.
- Performs and handles human peripheral blood for processing and product manufacture.
- Coordinates and manages supply inventory.
- Works closely and collaborates effectively with other departments including Immunology and Target Discovery.
- Acts 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 or equivalent job-related experience.
- Basic knowledge of primary cell culture and aseptic handling of cultures.
- Experience using various relevant equipment including, but not limited to cell separation devices, automated cell counters, flow cytometers, and FACS sorters.
- Experience with growing t-lymphocytes or dendritic cells is preferred.
- Experience in clinical cell process and equipment operations.
- Industry experience related to process development, scale up or manufacturing is preferred.
Other Skills and Abilities
- Make sound decisions and approach problems with curiosity and open-mindedness.
- Independent working, analytical reasoning and the ability to communicate effectively.
- Careful editing and documenting of results.
- Constant striving for excellence.
Job Type: Full-time
- Relevant: 1 year (Required)
- GMP Manufacturing: 2 years (Preferred)
- * Basic knowledge of primary cell culture: 2 years (Preferred)
- using cell separation devices, automated cell counters: 2 years (Preferred)
- United States (Preferred)
- Paid time off
- Health insurance
- Dental insurance
- Healthcare spending or reimbursement accounts such as HSAs or FSAs
- Other types of insurance
- Retirement benefits or accounts
- Gym memberships or discounts
- Flexible schedules