Manager/Sr. Manager, Analytical Development

San Diego, CA

JOB TITLE: Manager/Sr. Manager, Analytical Development
EFFECTIVE DATE: 9/1/2019
CLASSIFICATION: Exempt
FUNCTIONAL AREA: CMC
WORK LOCATION: San Diego, CA
SUPERVISOR: Director, Analytical development
MANAGERIALLY RESPONSIBLE FOR: None

ESSENTIAL JOB FUNCTIONS:

  1. 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.
  2. Provide analytical support to formulation development, drug substance and drug product manufacturing process development.
  3. Provide technical input in OOS, OOT, anomalous results investigation, identify root cause.
  4. Assemble data tables for regulatory submissions. Review, prepare and deliver technical documents for regulatory submissions.
  5. Contribute to setting specifications for drug substance and products, regulatory starting materials, intermediates, and raw materials.
  6. Contribute to developing and implementing analytical strategies for various development stage projects to achieve optimal results.
  7. Identify analytical science capabilities and technology tools needed to enable manufacturing process development, QC testing, and new drug candidate formulation development.
  8. Apply scientifically-driven thinking to design and implement study protocols to support analytical activities in drug development.
  9. Independently apply technical and management expertise to meet goals, timelines and make technical and management decisions to keep projects on track.
  10. Ensure timely preparations, review and approval of technical reports and documents to support regulatory submissions.

JOB SPECIFICATIONS:

  1. BS/MS degree in chemistry or pharmaceutics or equivalent
  2. 10+ years of relevant working experience in analytical development in pharmaceutical industry
  3. Good understanding of cGLP/cGMP principles, ICH guidelines
  4. Extensive analytical development background and hands on experiences with working knowledge of chemistry, analytical and pharmaceutical science.
  5. Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
  6. Have both broad and in-depth knowledge as well as hands-on experience in modern analytical chemistry techniques. Outstanding problem-solving abilities.
  7. Excellent interpersonal/ organizational skills and the ability to multi-task.
  8. Strong oral/ written communication skills.
  9. Strong computer skills.
  10. Strong leadership and collaboration skills
  11. Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment
  12. Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment
  13. Positive, adaptable, can-do attitude with quick learning ability
  14. 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 careers@kuraoncology.com