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.
We are currently seeking an Associate Director/Director, Chemical Development and API Manufacturing to join our experienced drug development team in San Diego. He/she will serve as the subject matter expert and lead the API process research/manufacturing function, mostly through external CMOs. 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:
- Design and implement phase appropriate API supply strategies to support programs at various stages from preclinical through commercial.
- Work with project teams to identify drug substance needs, manage and optimize aggressive project timelines, oversee the development of technical solutions to ensure smooth API processes demonstration and delivery.
- Guide external third parties through process research/development, technology transfer, optimization, qualification and validation of the activities related to DS manufacturing operations.
- Oversee and manage contract manufacture organization (CMO) to prepare manufacturing batch records, product development reports and other development-related documents. Be on-site, as necessary.
- Ensure that all development and manufacturing activities are conducted in a manner consistent with regulatory requirements while integrating quality by design and quality risk management principles into the development of the API process.
- Author and review of CMC sections for regulatory filings.
- Ph.D. or equivalent in synthetic organic chemistry
- 10+ years of relevant industry experience in process research and API manufacturing
- Knowledge of manufacturing processes and methods for cost-control, quality improvements, yield improvements and manufacturing efficiency
- Late stage development and commercialization experience is a plus
- Knowledge of cGMP guidelines, international and FDA regulations pertaining to the API production
- Experience with managing outsourced projects with contractors
- Strong leadership and collaboration skills
- Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment
- Strong written and communication skills
Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to firstname.lastname@example.org