Associate Director, Formulation Development
KSQ Therapeutics, United States
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 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.
Position Summary:
KSQ is seeking a highly motivated and versatile Associate Director, Formulation Development. Reporting to the Head of Small Molecule amp; Oligonucleotide CMC, the successful candidate will be responsible for the phase appropriate technical development and manufacturing of small molecule drug products using an external network of providers.
This position is integral to the advancement of KSQ’s lead small molecule KSQ-4279, and will collaborate closely with internal and external stakeholders in the broader program team. 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 may also provide support for KSQ’s cell therapy programs (sgRNA formulation) on a part time basis.
Requirements
Responsibilities
- Provide strategic technical leadership and oversight for small molecule formulation development (process and analytical development, GMP manufacturing)
- Collaborates in cross-functional teams, both internally and with third party CDMOs to define project objectives
- Ensure timely delivery of materials with appropriate quality attributes through active project management. Identify risks and take appropriate action to drive resolution that meets team and program needs.
- Build and maintain strong professional relationships both internally and with external development partners
- Assist in due diligence efforts to assess technical capabilities for vendor selection and preparation of RFPs.
- Establish and maintain an understanding of current trends and emerging process technologies in small molecule formulation development, including bioavailability enhancement
- Authors technical summaries/reports and drug product sections of regulatory filings.
- Presents results and progress of drug product programs to internal and external audiences as appropriate.
- Supports sgRNA formulation development programs as needed
Key Qualifications
- Ph.D. or M.S in pharmaceutical sciences or related discipline with 8+ years of experience in drug product process development
- Extensive formulation and process development expertise across a broad range of dosage forms
- Experience developing phase appropriate drug product specifications and control strategies (experience with process validation and commercial manufacturing preferred)
- Experience in the preparation and review of regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers)
- 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
- 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.