Associate Director, Adoptive Cell Therapy CMC Lead

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KSQ Therapeutics Cambridge , MA 02238

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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.

KSQ Therapeutics is seeking an agile and highly motivated individual to join our Quality & Technical Operations team as an Adoptive Cell Therapy CMC Lead. The individual in this role will support KSQ engineered tumor infiltrating lymphocyte (eTILTM) programs through leadership of CMC initiatives to define products, establish operational readiness for GMP clinical manufacturing, and enable regulatory submissions. The role will entail planning and execution of key CMC projects, and it will interface cross-functionally with internal and external partners. This is an opportunity to become an integral part of our work to bring KSQ adoptive cell therapies to patients!

Requirements

Key Responsibilities:

Plan and execute CMC projects that support eTIL product definition and enable operational readiness for GMP clinical manufacturing

Drive eTIL CMC regulatory efforts, including compiling content and writing IND sections and supporting documentation

Work with SMEs to establish control strategies and knowledge management systems

Own and implement change controls to support continuous improvement

Own and maintain CMC program risk assessments

Evaluate CMC strategic decisions

Apply CMC expertise to project deliverables, problem solving, and strategic planning

Identify and escalate business-critical issues affecting project and timelines as necessary, providing recommendations, mitigations, and potential solutions

Collaborate with Process Development, Analytical Development, Manufacturing, Quality, Quality Control, Research, Clinical, Regulatory, Finance, and Alliance & Program Management functions to ensure successful project execution and to meet company goals

Perform duties within KSQ Quality Systems and in accordance with GMP requirements

Key Qualifications:

Degree in science, engineering, or biotechnology-related field BS/MS with 10+ years of relevant industry experience or PhD with 5+ years of relevant industry experience

Technical expertise and applied experience with process development, analytical development, GMP manufacturing operations, and/or CMC regulatory management for biological products

Technical expertise in cell & gene therapy, including knowledge of gene editing

Strong technical project management and leadership skills

Strong technical and regulatory writing skills

Familiarity with operational use of Quality Systems, including risk management, change control, OOS, deviation management, root cause analysis, and CAPA management

Demonstrated commitment to Quality

Strong planning, organization, project execution, and communication skills

Interpersonal skills to work within a project team setting, across internal functions, and with external partners

Experience interfacing with external partners and vendors

Able to work in hybrid work-from-home/office mode

Covid-19 vaccination is a condition of employment at KSQ, subject to reasonable accommodation where required by law. Employees must be fully vaccinated by date of hire to be considered.

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