Cytoimmune Therapeutics is hiring new team members who believe in the potential of engineered natural killer (NK) cells as off-the-shelf allogeneic cellular therapy products for the potential treatment of several diseases across multiple therapeutic areas. We are a fast growing, patient-focused team located in Toa Baja, Puerto Rico.
As a Senior Associate Scientist or Associate Scientist, Analytical Operations, you will help build the Analytical Operations team at Cytoimmune Therapeutics as follows:
· Join an innovative, multi-disciplinary team developing and implementing characterization strategies, analytical methods, and data analysis to support the advancement of Cytoimmune Therapeutics pipeline.
· Support method optimization, method qualification, method transfer or validation activities of characterization and release assays for identity, purity, strength,and potency for Cytoimmune Therapeutics cell therapy programs.
· Provide high-quality results to Process Development teams using manual and automated lab equipment.
· Help in the operation and maintenance of the lab and equipment.
What you’ll do
· Independently participate in the optimization, qualification, implementation, and execution of characterization and release assays for identity, purity, strength, and potency of Cytoimmune Therapeutics cell therapy programs.
· Perform sample testing to support Process Development teams using a variety of techniques: flow cytometry, ELISA, cell counting methods, cell-based potency, qPCR, ddPCR, SDS-PAGE, Western blot, and HPLC.
· Assist in analyzing experimental data, summarizing results and preparing technical reports, qualification and/or validation protocols, qualification and/or validation reports, and CMC regulatory submissions.
· Participate in the support of analytical activities at quality control (QC) lab for method qualification/validation, assay performance trending and troubleshooting.
· Author, review, and approve SOPs.
· Manage inventory of samples, critical reagents, and cell banks for assay development or controls.
· Generate and communicate experimental plans effectively to stakeholders in Analytical Operations, Quality Control, and Process Development.
· Analyze experimental data and ensure timely documentation and record keeping in Electronic Notebook.
· Responsible for documentation of experimental data, generation of high-quality written study protocols, technical reports, and oral presentations.
· Improves operational efficiency in the laboratory
In addition to the above, the Senior Associate Scientist:
· Owns analytical method qualification per ICH Q2(R1) and trending of assay performance using statistical quality control tools (i.e., Westgard rules, Levey-Jennings charts, etc.).
· Generates and maintains cell banks of cell lines used for in vitro and in vivo assays, including feeder cells, tumor cell lines, NK cells and genetically modified cells.
· Ensures a productive and development rich environment, provides training/ mentoring for junior staff and leverages expertise in laboratory technology.
What we’re looking for
· Education and Behavioral Competencies
· BS in immunology, cell biology, biology, chemistry, pharmaceutical sciences, engineering, or related scientific discipline with 2+ years of relevant laboratory experience, in academic, pharmaceutical or biotechnology settings.
For the Senior Associate Scientist
· MS in immunology, cell biology, biology, chemistry, pharmaceutical sciences, engineering, or related scientific discipline with 1-3 years of relevant laboratory experience, in academic, pharmaceutical or biotechnology settings.
· Must have direct experience performing two or more method types:
· Flow cytometry
· Cell-based functional assays
For the Senior Associate Scientist
· Must have direct experience performing three or more of the above-indicated method types.
· Teamwork – Ability to work well in highly cross functional team environment and across functions.
· Knowledge Sharing – Ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables, and models for others to use.
· Knowledge and Skills
· Intermediate statistical knowledge for analytical data analysis.
· Ability to use literature to design feasibility studies.
· Excellent oral and written communication skills to present data and strategy.
· Analytical and Problem-Solving Skills – Able to troubleshoot critical issues or problems and determine causes and possible solutions.
· Resource Management -Ability to manage one’s time within individual and organization-wide goals and timelines.
In addition to the above, the Senior Associate Scientist has expertise in mammalian cell culture techniques.
What will separate you from the crowd
· Experience with characterizing a variety of cell types using multi-color flow cytometry.
· Experience developing or evaluating novel reagents for flow cytometry.
· Strong experimental skills on in-vitro cell-based functional studies, cell culture and maintenance, and potency assays for studying cell therapy or biological drug products.
· Experience with method qualification, method validation, and method transfer to Quality Control.
· Experience with laboratory automation for flow cytometry and cell-based assay workflows.
· Experience working in a regulated GxP environment.
· Familiarity with regulatory guidelines from the FDA, ICH, and USP.
· Familiarity with development and/or commercialization of cell-based or protein-based therapeutics, including the development of analytical methods.
· Excellent organizational and communication skills.
· Able to work independently and function within a collaborative/team-oriented environment
· Innovative, critical, and creative thinker, unafraid to propose aggressive solutions to complex problems.
What you should know
· Working safely in person on a predictable and regular basis is an essential job function for this position and CytoImmune Therapeutics requires that all individuals, subject to certain exceptions, be fully vaccinated against COVID-19.
Job Type: Full-time
Pay: From $60,000.00 per year
- Dental insurance
- Health insurance
- Paid time off
- Retirement plan
- Vision insurance
- Day shift
- Monday to Friday
Work Location: One location