At KSQ Therapeutics, we are always looking for strong leaders to join our team.
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About KSQ Therapeutics
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.
KSQ Therapeutics is seeking an exceptional and highly motivated Director / Senior Director to join our Technical Operations team as Head of Small Molecule Process Chemistry. The process chemist in this role will be responsible for establishing GMP manufacturing processes for our small molecule programs. As the manufacturing process owner and SME, this individual will act as the primary interface with CDMO partners to drive process development, facilitate scale-up and tech transfer, and execute GMP manufacturing campaigns to support early-stage clinical trials. This individual will report to the Head of Technical Operations and will join a newly-forming team that will establish the technical operations foundation at KSQ Therapeutics.
• Lead KSQ small molecule CMC programs through the development and establishment of GMP manufacturing processes to support early-stage clinical trials.
• Hold role of KSQ manufacturing process owner and primary technical operations interface with CDMO partners.
• Collaborate effectively with CDMO partners to design and implement robust process and analytical control strategies that serve as the basis for process optimization, technology transfer, scale-up, and validation.
• Support establishment of material supply chains.
• Provide oversight for manufacturing campaigns, including representing KSQ as person-in-plant.
• Leverage subject matter expertise to author and review batch production records; analyze process data; evaluate quality event investigations, CAPAs, and change controls; and resolve technical issues.• Play a key role in developing, reviewing, and approving CMC regulatory submissions.
• PhD in chemistry with 12+ years of industry experience or BS/MS with 15+ years of comparable work-relevant experience in the field of small molecule drug development and/or manufacturing.
• Demonstrated expertise and a track record of success in advancing drug development programs from drug candidate nomination through IND filing and into clinical development.
• Extensive experience interfacing with and providing scientific guidance to CDMO partners, contributing to an overall proven ability to work efficiently in a hybrid model.
• Expertise in synthetic process chemistry, formulation development, and analytical method development.
• Experienced in process R&D, scale-up, and technology transfer.
• Experienced in supporting GMP manufacturing operations for small molecule products.
• Knowledge of phase-appropriate implementation strategies of QbD.
• Experienced in quality system operational requirements, including quality event investigation and resolution.
• Excellent verbal and written communication and interpersonal skills to work within a project team setting, across functions, and within industry collaborations.
• 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 as part of a fast-paced environment.
• Commitment to quality, attention to detail, and a team player mentality.
A competitive overall compensation package, including competitive base salary, bonus potential and stock options.