Job Overview
About the Company
CytoImmune Therapeutics is committed to finding a cure for cancer; we are developing cell-therapies targeting solid and liquid tumors. Curing cancer is demanding work; we know it is a marathon and not a sprint: If we succeed, we will change the lives of patients and their families. We are working on curing cancer inside and outside of the discovery lab.
About the role
The Senior Scientist leads the design, logistics, and execution of in vitro studies to evaluate the functionality and composition of CytoImmune’s cell therapy products using a positive, proactive, and collaborative team player approach. In addition, this individual supports the generation of regulatory documents for CMC activities.
As a Senior Scientist, you will help build the Process Development team at CytoImmune Therapeutics as follows:
· Join a ground-braking interdisciplinary team developing and executing innovating characterization approaches, analytical assays, and data analysis to support the advancement of CytoImmune Therapeutics cell and gene therapy products (CAR-NK) for the treatment of cancer.
- Support analytical procedures to characterize the identity, purity, strength, and potency for CytoImmune Therapeutics cell therapy programs.
- Provide technical leadership across process development and analytical methods initiatives.
- Identifie opportunities for further optimization of analytical assays and implementation of new methodologies to support characterization of pipeline CAR-NK products.
Responsibilities and Duties
What you'll do
- Independently design, plan, and perform characterization studies of in-process and final CAR-NK products using cell-based functional in vitro assays and various techniques including ELISA, multiparameter flow cytometry, and qPCR with high level instructions.
- Generate, maintain, and characterize master banks of cell lines used for in vitro studies, including feeder cells, tumor cell lines, and genetically modified cell lines.
- Analyze and interpret experimental data and ensure timely documentation in Electronic Notebook.
- Implement resolution to technical challenges, communicate effectively and present complex data within cross-functionally and in scientific conferences.
- Drive project timelines and deliverables while meeting internal quality and data integrity requirements.
- Author/review analytical assay reports, protocols, SOPs, and technical documents for regulatory filings.
- Ensure a positive, proactive, productive, and development rich environment; provide training/mentoring for technicians and scientists across departments and leverage expertise in laboratory technology.
- Support the Analytical Method Qualification team on assay qualification/validation.
- Improve operational efficiency in the laboratory.
Qualifications
What we’re looking for
* Education and Behavioral Competencies
- PhD in Immunology, Cancer Biology, Cellular and Molecular Biology, or related scientific discipline with 8+ years of research laboratory experience, in academic, or industry settings.
- Demonstrated research career with publications in peer-reviewed journals.
- Innovative, critical and creative thinker, unafraid to propose solutions to complex problems.
- Strong background performing mammalian cell culture techniques (both tumor and primary immune cells), in vitro immunoassays (eg cytotoxicity, cytokine analysis), multi-parameter flow cytometry, DNA extractions, fluorescent microscopy, qPCR.
- Ability to independently conceive experimental designs, make detailed observations, analyze and interpret data, propose improvements to and troubleshoot experimental protocols.
- Strong quantitative, qualitative skills and ability to adapt to changing needs as experiments develop or priorities change.
- Ability to train, supervise, and mentor junior scientists.
- Extensive experience with analytical methods for cell and gene therapy, including in depth knowledge of flow cytometry and test methods, such as qRT-PCR and immunological assays
- Attention to detail – ability to conduct studies in a precise manner to ensure data accuracy and successful experiments.
- Critical thinking and Problem solving – Ability to interpret data accurately as well as to identify and find solutions to obstacles and technical issues.
- Collaboration - Ability to work well in highly cross functional team environment and across functions.
- Self-motivated with ability to operate effectively within a fast-paced work environment and to work with minimal direction.
- Detail oriented with strong organization and project management capabilities.
- High energy level and a positive outlook coupled with the requisite "can do" attitude.
- Strong written and oral communication skills are essential; ability to present thoughts clearly and concisely.
* Knowledge and Skills
- Intermediate statistical knowledge for analytical data analysis.
- Ability to use scientific literature to plan feasibility studies.
- Resource Management - Ability to manage one’s time within individual and organization-wide goals and timelines.
- Strong knowledge in MS Word, Excel, Power Point as well as specialized software including FlowJo, GraphPrism or Illustrator.
Preferred Qualifications
What will separate you from the crowd
- Experience in isolation and culture of primary immune cells, including T-cells and NK cells.
- Experience with genetic manipulation of primary cells using transient transfections or viral transduction techniques.
- Experience with high-throughput flow cytometry and cytokine screening.
- Experience Conducting In Vivo Studies
- Familiar with regulatory guidelines from the FDA, ICH, and USP and early-stage IND filings.
- Experience working in a regulated GxP environment.
Working Conditions
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.
- Bloodborne Pathogen Certification is required.
- Other immunizations (eg Hepatitis B) may be required.
- Flexibility with working on occasional weekends is required.
Job Type: Full-time
Pay: From $75,000.00 per year
Medical specialties:
Experience:
- Molecular biology: 1 year (Preferred)
- Immunoassays (ELISA): 5 years (Preferred)
- Flow Cytometry: 5 years (Preferred)
- Molecular Tech (PCR, RTPCR): 5 years (Preferred)
- Cell culture: 5 years (Preferred)
Ability to Commute:
- Toa Baja, PR 00949 (Required)
Work Location: In person