Careers

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 clinical-stage biotech 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.

This position will oversee the Analytical Development function and support the development and implementation of procedures to ensure that KSQ’s testing and control strategy is in compliance with US and international regulations, laws, and guidelines that oversee the manufacturing and testing of investigational clinical trial materials. This position will provide oversight of analytical testing both internally and externally, including but not limited to technical transfer, method qualification and validation as well as some support of routine GMP testing (in process, lot release and stability testing). This position will assemble, review and trend release, generating reports as necessary to support specification and expiry setting. Analytical method support will include but will not be limited to continuous monitoring of method performance (e.g., control charting, invalid rates, etc.), investigation/OOS management, data integrity reviews, and authoring and/or review of relevant sections of IND/IMPD (i.e., raw materials testing and control, method validation, specifications, batch analysis, reference standard, and stability).

Requirements

Duties/Responsibilities:

• Manages the day-to-day laboratory activities of AD analysts
• Manages the performance of analytical methods in-house to support process development and regulatory-enabling studies
• Provides broad-based Method Validation/Transfer expertise related to analytical and biological assays such as Flow Cytometry, qPCR, ELISA, nucleic acid quantification, sequencing, and current USP methods and monographs as well as associated instrumentation
• Evaluation of newly developed in-house methods for suitability and acceptability
• Ensures the successful transfer of new methods to External Partners and the validation/re-validation of existing methods and instrumentation are performed as required and in accordance with applicable regulations.
• Coordinates testing with external contract testing laboratories as well as required assay validation activities.
• Perform routine technical reviews of internal and external release test data.
• Trends control, stability, reference standard, and release data as applicable
• Prepare and conduct routine technical reviews of validation protocols and reports.
• Support new IND applications and drafting relevant sections of CMC submissions

Required Skills and Experience

• Minimum of a BS in Biology, Chemistry, or related scientific discipline
• 8-10 years of GMP experience in the pharma or biotech industry
• Minimum of 5 years' experience with increasing responsibilities in management of external cGMP lab operations and method validation
• Minimum of 3+ years' supervisory/leadership experience.
• Must be able to stand for long periods of time
• This position is primarily office/lab-based