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At KSQ Therapeutics, we are always looking for strong leaders to join our team.
Contact us about current job opportunities.

A NOTE TO RECRUITERS

To be able to manage our flow of candidates we do not accept unsolicited resumes from any source other than directly from the candidates for current or future positions. Submission of unsolicited referrals and/or resumes in advance of a signed agreement between KSQ and the recruiter are deemed gratuitous and KSQ will not be obligated or bound in any way to pay any referral or other fees if such person is hired. Thank you in advance for your adherence to our process. For any hiring needs, please contact us.

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Associate Director/Director, Manufacturing Sciences & Technology (MSAT)

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.

At KSQ, we are using our CRISPRomics® discovery platform to systematically decode the entire genome and identify oncology and autoimmune disease targets that we can treat. Our Quality and Technical Operations team leads the development and supply of our therapies. Come join us… you just might discover that you were born to help us rewire human biology and cure disease!

Role Overview:

KSQ Therapeutics is seeking a collaborative and highly motivated leader to establish and drive a Manufacturing Sciences & Technology (MSAT) function to support clinical manufacture of KSQ adoptive cell therapy products.

This role will entail manufacturing process ownership and responsibility for oversight of external GMP clinical manufacturing activities. This includes technology transfer, process control strategies, process monitoring, problem solving, risk assessment, and continuous improvement. You will collaborate cross-functionally with both internal & external partners to ensure successful project execution and meet team goals.

This is an opportunity to become an integral part of our work to bring KSQ adoptive cell therapies to patients!

Requirements

KSQ Therapeutics is seeking a collaborative and highly motivated leader to establish and drive a Manufacturing Sciences & Technology (MSAT) function to support clinical manufacture of KSQ adoptive cell therapy products.

This role will entail manufacturing process ownership and responsibility for oversight of external GMP clinical manufacturing activities. This includes technology transfer, process control strategies, process monitoring, problem solving, risk assessment, and continuous improvement. You will collaborate cross-functionally with both internal & external partners to ensure successful project execution and meet team goals.

This is an opportunity to become an integral part of our work to bring KSQ adoptive cell therapies to patients!

Key Responsibilities:

  • Establish and lead Manufacturing Sciences & Technology (MSAT) function to support clinical manufacture of KSQ adoptive cell therapy products
  • Build a high-performing team and coach/develop each team member to realize their full potential
  • Own established clinical manufacturing processes, including responsibility for technology transfer, process control strategies, process monitoring, problem solving, risk assessment, and continuous improvement
  • Partner with external manufacturers to ensure the success of GMP clinical manufacturing activities, including training, troubleshooting, data monitoring, process improvements, and documentation management
  • Design and execute lab-based studies to support manufacturing and expand our process knowledge
  • Partner with Data Science team to build, maintain, and apply databases for manufacturing data analysis and process monitoring
  • Support CMC data analysis, technical writing, and strategy for regulatory filings
  • Collaborate cross-functionally, including interfaces with Manufacturing, Quality Control, Quality Operations, Clinical Operations, Process & Analytical Development, Research, Data Science, Alliance & Program Management, Finance, and Legal partners
  • Own and execute work in accordance with GMP requirements and within KSQ quality systems

Key Qualifications:

  • Degree in science, engineering, or biotechnology-related field – BS/MS with 8+ years of relevant industry experience or PhD with 4+ years of relevant industry experience
  • Previous experience in MSAT oriented role supporting clinical or commercial GMP manufacturing operations for biological products, cell & gene therapy preferred
  • Experienced as a people manager
  • Interpersonal skills to work within a project team setting, across internal functions, and with external partners
  • Strong influencing capabilities with an ability to effectively interact and communicate at all levels of an organization
  • Ability to work hands-on in laboratory as needed
  • Direct experience with operational use of Quality Systems, including risk management, change control, document control, investigations, deviation management, CAPA management, and training
  • Demonstrated commitment to Quality
  • Strong planning, organization, project execution, and communication skills
  • Strong technical and regulatory writing skills
  • Hybrid work from home/office per current KSQ policy
  • Travel to depend on need, expected <15%

KSQ Therapeutics is proud to be an Equal Opportunity Employer.

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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