||Manager/Sr. Manager, Analytical Development
||San Diego, CA
||Director, Analytical development
|MANAGERIALLY RESPONSIBLE FOR:
ESSENTIAL JOB FUNCTIONS:
- Manage CRO/CMO for analytical activities for drug substance and product: method development, method validation, characterization, reference standard qualification, release and stability testing, etc. Review raw analytical data and trend stability data. Prepare stability study reports and other analytical related reports.
- Provide analytical support to formulation development, drug substance and drug product manufacturing process development.
- Provide technical input in OOS, OOT, anomalous results investigation, identify root cause.
- Assemble data tables for regulatory submissions. Review, prepare and deliver technical documents for regulatory submissions.
- Contribute to setting specifications for drug substance and products, regulatory starting materials, intermediates, and raw materials.
- Contribute to developing and implementing analytical strategies for various development stage projects to achieve optimal results.
- Identify analytical science capabilities and technology tools needed to enable manufacturing process development, QC testing, and new drug candidate formulation development.
- Apply scientifically-driven thinking to design and implement study protocols to support analytical activities in drug development.
- Independently apply technical and management expertise to meet goals, timelines and make technical and management decisions to keep projects on track.
- Ensure timely preparations, review and approval of technical reports and documents to support regulatory submissions.
- BS/MS degree in chemistry or pharmaceutics or equivalent
- 10+ years of relevant working experience in analytical development in pharmaceutical industry
- Good understanding of cGLP/cGMP principles, ICH guidelines
- Extensive analytical development background and hands on experiences with working knowledge of chemistry, analytical and pharmaceutical science.
- Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
- Have both broad and in-depth knowledge as well as hands-on experience in modern analytical chemistry techniques. Outstanding problem-solving abilities.
- Excellent interpersonal/ organizational skills and the ability to multi-task.
- Strong oral/ written communication skills.
- Strong computer skills.
- 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
- Positive, adaptable, can-do attitude with quick learning ability
- Ability to travel and work flexible hours, as required.
Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to firstname.lastname@example.org