Manager/ Senior Manager, Stability – San Diego, CA

San Diego, CA

Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of.

At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics.

As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality.

To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions.

Manager/ Senior Manager, Stability

We’re looking for an Manager or Senior Manager, Stability to join the Analytical Development group. This position reports to the Director, Analytical Development. This is a newly created position due to company growth.

ESSENTIAL JOB FUNCTIONS:

  • Manage all Kura development and GMP stability studies for Kura pipeline projects, including those for regulatory starting materials, intermediates, drug substances and drug products, and maintain the stability schedule for each study.
  • Propose appropriate stability study design per material and project needs, review and approve CMO-generated stability protocols, stability reports and associated raw data records within agreed time frame.
  • Enter all related stability and SOP documentation into EDMS and manage document control aspects for stability and related QC elements.
  • Coordinate with Quality Assurance to establish retesting and expiration periods and change controls for all specification documents for drug substance, drug product, and clinical trial materials as subject matter expert.
  • Coordinate with CMOs and provide technical input on stability-related investigations (OOE, OOS, etc.) to ensure each investigation is conducted and completed per applicable SOPs.
  • Perform stability trending analysis and keep CMC team updated on study status and issues.
  • Assign and document retest period or expiry date based on available stability data and applicable guidelines.
  • Assemble stability data tables, write the stability sections, and contribute to the reviews for regulatory submissions.
  • Contribute to setting specifications for drug substance and products, regulatory starting materials, intermediates, and raw materials.

JOB REQUIREMENTS:

  • BS/MS degree in chemistry or pharmaceutics or equivalent.
  • 5+ years of relevant working experience in analytical development in pharmaceutical industry.
  • Good understanding of cGLP/cGMP principles and ICH guidelines.
  • Extensive analytical development background and hands on experiences with working knowledge of chemistry, analytical and pharmaceutical science.
  • Working knowledge of EDMS quality systems such as Veeva Vault.
  • Detail-oriented and 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.
  • Strong leadership, teamwork, organization, 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.

THE KURA PACKAGE

  • Career advancement/ development opportunities
  • Competitive comp package
  • Bonus
  • 401K + Employer contributions
  • Generous stock options
  • ESPP Plan
  • 20 days of PTO to start
  • 14 Holidays + 3 Floater Holidays (Including Winter Break), Summer Hours
  • Generous Benefits Package with a variety of plans available with a substantial employer match
  • Paid Paternity/Maternity Leave
  • In-Office Catered lunches
  • Home Office Setup
  • Cell Phone and Wellness Stipend
  • Commuter Stipend (Boston Office)
  • Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!

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. Our goal is to help patients with cancer lead better, longer lives. Kura Oncology has offices in San Diego, California, and Boston, Massachusetts.

Kura’s pipeline consists of Tipifarnib and KO-539. Tipifarnib is a farnesyl transferase inhibitor that recently received Breakthrough Therapy Designation (BTD) for the treatment of patients with certain head and neck cancers that carry HRAS mutations. Tipifarnib will also be evaluated in combination with an inhibitor of PI3Kalpha to treat between 20-50% of patients with HNSCC, the 7th largest cancer worldwide. KO-539 is an inhibitor of the menin/MLL interaction, which is are critically important for survival, growth, and proliferation leukemic blasts. Kura recently presented preliminary clinical data for KO-539 at the 2020 American Society of Hematology (ASH) meeting that demonstrated that it demonstrates favorable safety and tolerability and compelling evidence of activity in genetically defined AML patients.

Kura Oncology is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. To apply, please submit your resume to careers@kuraoncology.com