Description: Kura Oncology is a clinical-stage biopharmaceutical company discovering and developing personalized therapeutics for the treatment of solid tumors and blood cancers. The company’s diverse pipeline consists of small molecules that target cancer signaling pathways where there is a strong scientific and clinical rationale to improve outcomes by identifying those patients most likely to benefit from treatment. Kura Oncology’s approach to drug development is focused on rapidly translating novel science into life-saving medicines. Kura Oncology was founded in 2014 and has offices in La Jolla, California and Cambridge, Massachusetts.
Senior Manager or Senior Scientist, CMC
We are currently seeking a CMC Senior Manager/Senior Scientist to join our experienced drug development team in San Diego. To advance our pipeline of investigational therapies in varied clinical development stages, he/she will be engaged in a broad range of CMC related activities such as investigational drug product supply management, quality control and quality assurance of drug product production, regulatory filings etc. Close and frequent interactions with internal functional areas such as clinical operation, regulatory affairs and external partners are expected as well. A strong team player who enjoys oncology drug development and has the ability to communicate and collaborate in an interdisciplinary environment is essential.
Primary responsibilities of this position will include:
- Working cross-functionally with internal and partner stakeholders in clinical operations, quality assurance, regulatory affairs and manufacturing, manage supply of Investigational Product (IP) including packaging, labeling and distribution through all stages of clinical development to ensure timely and uninterrupted supply of IP for assigned clinical studies
- Manage vendors for packaging, labeling and distribution operations and supporting services for assigned clinical studies and programs
- Monitor global clinical supply inventory via tracking of specific milestone dates and adjust drug distribution plan accordingly
- Provide quality control support for clinical trial material production such as data/document review of testing results, analytical method development/validation/transfer, stability study and OOS investigation
- Administration of Electronic Document Management Systems (EDMS) and document control for the CMC documents
- Dossier data management and review for regulatory filings
- Other duties as requested by supervisor
- A Ph.D. in chemistry with minimum of 5 years of industry experience in pharmaceutical/biotechnology industry OR a BS with at least 10 years of related experience.
- A thorough understanding of analytical chemistry and extensive experience in QC
- Strong organizational, analytical and interpersonal skills
- Understanding of regulatory requirements for global clinical supply distribution including testing and packaging/labeling/distribution
- Prior experience managing third parties, domestic and international external service providers
- A strong understanding of cGMP regulations.
- Excellent verbal and written communication skills
- Flexible and quick learner
- Knowledge of general computer skills
- Ability to work in a fast paced, dynamic environment with multiple projects
Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to email@example.com