Associate Director, Oligonucleotide CMC

Company: KSQ Therapeutics
Location: Cambridge
Posted on: May 3, 2021

Job Description:

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 with remarkable concordance to 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 preclinical-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. We maintain a lively and inquisitive environment in the heart of the vibrant Kendall Square (KSQ) neighborhood. Position Summary: KSQ is seeking a highly motivated and versatile Associate Director, Oligonucleotide CMC. The successful candidate will be responsible for the phase appropriate technical development of oligonucleotide drug substances and drug products (sgRNA) using an external network of providers. This position is integral to the advancement of KSQs growing portfolio of adoptive cell therapy programs and will collaborate closely with internal stakeholders in KSQs cellular process development group and target discovery group. The scope of this role encompasses authorship of CMC content for regulatory submissions in collaboration with other KSQ functional groups, as well as developing and actively managing appropriate timelines/budgets for all activities. This position will also provide support for KSQs small molecule CMC programs on a part time basis. Requirements + Provide technical leadership in support of oligonucleotide DS and DP development programs (process and analytical development, GMP manufacturing) + Define analytical test plans, including characterization, functionality, and stability analysis. + Collaborates in cross-functional teams, both internally and with third party CDMOs to define project objectives + Ensures timely delivery of materials with appropriate quality attributes through active project management. Identifies risks and takes appropriate action to drive resolution. + Builds and maintains strong professional relationships both internally and with external development partners + Assists in due diligence efforts to assess technical capabilities for vendor selection and preparation of request for proposals. + Establish and maintain an understanding of current trends, emerging process technologies and ensure full awareness of current and emerging global capabilities for oligonucleotide production. + Authors technical summaries/reports and CMC sections of regulatory filings. + Presents results and progress of CMC programs to internal and external audiences as appropriate. + Supports small molecule CMC programs (repeat manufacturing, logistics, etc) as needed Key Qualifications + Ph.D. or M.S in chemistry, biochemistry (or other relevant physical or life sciences discipline) with 7+ years of experience in oligonucleotide drug substance and drug product process development + Strong technical background in oligonucleotide chemistry, including synthesis methods, deprotection, purification, isolation techniques, and analytical characterization. Fill/finish and lyophilization experience is desirable. + Experience developing phase appropriate oligonucleotide drug substance and drug product specifications and control strategies + Prior experience working in a virtual CMC development environment with external CDMO partners + Strong focus on collaboration. Building and maintaining good working relationships with internal and external stakeholders is essential. + Ability to work in a fast-paced and dynamic corporate environment with changing priorities, and meet time sensitive program deadlines + Excellent written and oral communication skills, including the maintenance of technical data and reports + Ability to travel (domestic and international) on an as-needed basis + An understanding of small molecule CMC technical development is a plus

Keywords: KSQ Therapeutics, Cambridge , Associate Director, Oligonucleotide CMC, Other , Cambridge, Massachusetts