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 a Director, Formulation to join our experienced drug development team in San Diego. He/she will serve as the subject matter expert and lead the formulation/manufacture process development 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:
- Drug product development from lead optimization to clinical development and through commercialization, and should have experience and/or knowledge in preformulation, formulation development, and process selection and scale up based on Quality by Design (QbD), oversight of GMP drug product manufacturing and global regulatory CMC (INDs, IMPDs, NDAs, MAAs).
- Design and conduct pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing activities on assigned projects.
- Define and develop appropriate primary packaging for the finished drug product as needed.
- Guide external third parties through technology transfer, process development, optimization, qualification and validation of the activities related to DP 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.
- Author and review of CMC sections for regulatory filings.
- Ph.D. or equivalent in pharmaceutical sciences or related field
- 10+ years of relevant industry experience in formulation/process development
- In depth knowledge and hands on experience on formulation and process development of small molecule oral an injectable dosage forms
- Manufacture experience is strongly preferred
- Late stage development and commercialization experience is a plus
- Thorough understanding of cGMP compliance and ICH guidelines
- 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; and an ability to work effectively with a diverse team of co-workers in a dynamic environment
Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to email@example.com