Senior Associate Scientist, Cellular Process Development
KSQ Therapeutics, United States
Job Description
At KSQ Therapeutics, we seek to understand the role of every human gene in each disease, each tissue, and each cell that we study. This comprehensive approach has resulted in a massive, experimentally derived dataset that we have found to be remarkably predictive of past successes and failures in oncology and immuno-oncology product development. Utilizing this approach, we also identified a number of opportunities for the development of new medicines. As a result, we have aggressively invested in these distinct, highly validated pathways for new drug development with the expectation that the medicines we create may become the next breakthrough products for patients.
Founded in late 2015, KSQ is a preclinical-stage biotech in Kendall Square that has rapidly advanced the field of CRISPR-enabled functional genomics, from in vitro cell autonomous screens to more complex genome-scale screens of immune cells in vivo. The company has expanded the scope of its technology to include multiple cell types and to unlock areas beyond oncology. KSQ is led by a team of accomplished industry experts in drug discovery and development. We maintain a lively and inquisitive environment in the heart of the vibrant Kendall Square (KSQ) neighborhood.
Position Summary:
The individual in this role is responsible for providing expertise to enable process development and process characterization of KSQ cell therapy products. The scope of the role spans early-stage process development through technology transfer for clinical manufacturing.
Process Development
- Provide critical laboratory support to process development activities in preparation for technology transfer to CDMO by optimizing protocols for T cell engineering, including: gene editing methods, culture conditions, and scale-up
- Design and perform experiments involving the isolation, engineering, expansion, and cryopreservation of gene modified T cells for the treatment of solid tumor malignancies
- Analyze data, interpret scientific results, author protocols and reports, and present scientific data to key internal stakeholders
- Support Design of Experiment (DoE) experiments using scale down models
- Independently manage and execute on key project workstreams while working collaboratively with members from other functional groups including research, translational medicine, and quality.
- Maintain critical raw material database and provide timely updates to inform decision making and scheduling
- Mentor and guide junior scientists in the design and execution of their work and career development
- Generate and maintain critical data in a highly organized manner
- Compile and present data to functional team
- Responsible for coordinating and/or preparing critical reagents as needed to support laboratory activities
- Manage physical inventory for raw materials
- This is a hands-on position and requires the candidate to have a flexible schedule based on experimental and company needs (including possible weekend work)
Technical Operations Infrastructure
- Assist with the establishment of Cellular Process Development (CPD) best practices for planning, executing, and documenting work (e.g., work practices, templates, etc.)
- Assist with risk-based assessments such as RCA and FMEA
Basic Laboratory
Requirements
- A BS/MS degree in chemical engineering, biotechnology, biology, or related discipline with 1-4 years of relevant industry experience
- Expertise in primary human immune cell isolation techniques and familiarity with common cellular therapy equipment such as Sepax, LOVO, controlled rate freezers, and CliniMACS is preferred
- Expertise in gene modification of primary cells using CRISPR/Cas9, mRNA transfection, or lentiviral/gamma-retroviral vector transduction
- Experience with standard immunological and functional assays such as multi-parameter flow cytometry, Luminex/ELISA/MSD, and cytotoxicity assays
- Experience with standard molecular biology techniques, including but not limited to: PCR, RT-PCR, qPCR, and Western blot
- Must possess strong organizational skills, attention to detail, and the ability to adapt to changing priorities in a fast-paced environment
- Ability to manage priorities and make decisions in a fast-paced environment to ensure deliverables are completed in a timely fashion
- Excellent communication skills and ability to handle confidential information and material appropriately
- Excellent computer skills, including Microsoft Excel and PowerPoint, GraphPad Prism, and FlowJo