Senior Scientist, Cellular Process Development
KSQ Therapeutics, United States
Job Description
About KSQ Therapeutics
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 enabling 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
- Design and execute experiments to support initial definition of baseline manufacturing process
- Develop a robust process control strategy
- Lead process development activities in preparation for technology transfer to CDMO by optimizing protocols for feeder cell manufacturing and qualification
- Maintain an electronic laboratory notebook (ELN) and assist in the generation and review of technical protocols, reports, and support documentation as needed
Technical/Manufacturing Operations
- Assist with the establishment of KSQ/CPD best practices for planning, executing, and documenting work (e.g., work practices, templates, etc.)
- Leverage subject matter expertise as needed to review batch production records; analyze process data; and assess quality events with potential process design or product impact
- Interface with internal functional collaborators and stakeholders
Basic Laboratory
- Oversee day-to-day activities in the lab, including coordinating preparation of critical reagents across functions as needed to support laboratory activities
- Generate and maintain critical data in a highly organized manner
- Compile and present data to functional team
- 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)
Requirements
- A BS degree in chemical engineering, biotechnology, biology, or related discipline with 7+ years in biotechnology/pharmaceutical industry, or a Masters degree with 5+ years relevant experience
- Demonstrated skill in primary human immune cell isolation techniques and mammalian cell culture, including culture of primary human T lymphocytes; standard immunological and functional assays such as multi-parameter flow cytometry, Luminex/ELISA/MSD, and cytotoxicity assays
- Experience in gene modification of primary cells using CRISPR/Cas9, mRNA transfection, or lentiviral/gamma-retroviral vector transduction; standard molecular biology techniques, including but not limited to: PCR, RT-PCR, qPCR, and Western blot
- Must possess strong organizational and communication skills; attention to detail; adaptability to changing priorities in a fast-paced environment; handle confidential information and material appropriately; commitment to quality; and ability to think critically and creatively
- Excellent computer skills, including experience with Microsoft Excel and PowerPoint, GraphPad Prism, and FlowJo (required)