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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, pleaseĀ contact us.

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Technical Operations Manager

Company

KSQ Therapeutics has built an industry-leading genome-scale precision functional genomics platform, called CRISPRomics, to pinpoint therapeutic nodes that directly correlate genomic function to disease with unprecedented certainty and speed. The company is deploying CRISPRomics for novel drug development across broad therapeutic areas and is advancing a proprietary pipeline of tumor- and immune-focused drug candidates for oncology. KSQ was founded by thought leaders in the field of functional genomics and pioneers of CRISPR screening technologies. The company is located in Kendall Square in Cambridge, Massachusetts.

Description

KSQ Therapeutics is seeking a versatile and highly motivated individual to join our Technical Operations team. The individual in this multi-faceted role will support definition and implementation of GMP manufacturing operations to support early-stage clinical trials across multiple drug product modalities (e.g., cell therapy, large molecule, small molecule). The role will entail leading CMC projects and representing KSQ as a technical liaison with external partners. This is an opportunity to join a newly forming team that will establish the CMC foundation at KSQ Therapeutics.

Responsibilities

  • GMP Manufacturing Readiness
    • Support development of robust process and analytical control strategies.
    • Represent KSQ as a technical liaison with external partners.
    • Collaborate with external partners to drive projects from end-stage development into GMP manufacturing.
    • Drive and/or support tech transfer activities.
    • Support implementation of material supply chains.
  • Manufacturing Operations Oversight
    • Provide effective technical oversight for CMO manufacturing campaigns, including representing KSQ as a manufacturing SME and person-in-plant.
    • Leverage subject matter expertise to review batch production records; analyze process data; evaluate quality event investigations, CAPAs, and change controls; and address technical issues.
  • Technical Operations Infrastructure
    • Work with KSQ Quality to instill GMP concepts into company culture.
    • Establish and maintain systems for manufacturing process monitoring.
    • Support CMC regulatory needs, including IND filings and regulatory responses.

Requirements

  • Minimum BS in science, engineering, or related field
  • 7-10 years relevant biotechnology industry experience
  • Direct experience supporting development and/or manufacturing activities across multiple drug product modalities (e.g., cell therapy, large molecule, small molecule)
  • Strong process data analysis and technical communication skills
  • Experience working within GMP operations environments
  • Experience interfacing with external CDMO partners
  • Experience in operational use of quality systems, including quality event investigation and resolution
  • Demonstrated commitment to quality
  • Interpersonal skills to work within a project team setting, across internal functions, and with external partners
  • Able to travel periodically, both domestically and internationally, to develop and foster collaborations with CDMO partners and to oversee manufacturing campaigns
  • Ability to independently solve problems and to think both critically and creatively in a fast-paced environment

Apply Now!