Senior Manager

Kura Oncology
Posted on

Type

Executive / senior industry position

ESSENTIAL JOB FUNCTIONS:

  1. Drug product development from lead optimization to clinical development and through commercialization, and should have experience in pre-formulation, formulation development, and process selection and scale up based on Quality by Design principles
  2. Design and conduct pre-formulation, formulation and process development, scale-up and clinical manufacturing activities, including primary packing
  3. Develop stage-appropriate dosage forms (e.g. tablets/capsules, solution/suspension-based formulations, parenterals, etc.) for clinical and commercial use
  4. Author and review development reports, technical memos, batch records, and relevant CMC sections for various regulatory filings (IND, IMPD, NDA, MAA)
  5. Create and manage drug product risk assessment and risk register
  6. Serve as a formulation SME on project teams and/or sub-teams
  7. Guidance and oversight of CMOs through technology transfer, process development, optimization, qualification and validation of activities related to DP manufacturing operations
  8. Oversight of CMOs for formulation and process development, scale up and GMP manufacturing activities including packaging and labeling. Be on-site, as necessary.

JOB SPECIFICATIONS:

  1. PhD in Pharmaceutical Sciences, Chemical Engineering or related Physical Sciences and 3+ years of experience working in formulation development in the pharmaceutical or biotechnology industry; or MS with 5+ years of relevant formulation development experience
  2. In-depth knowledge and hands-on experience in formulation and process development of small molecule oral solid and injectable dosage forms, including pediatric formulations
  3. Proven experience managing scale-up and manufacturing of pharmaceutical dosage forms
  4. Experience with a range of dosage forms (oral solids, IV solutions, lyophilization-based IV formulations), and LCM formulation strategies
  5. Late stage development and commercialization experience is strongly preferred
  6. Thorough understanding of cGMP compliance and ICH guidelines
  7. Experience writing CMC sections in regulatory filings
  8. Direct experience managing CMOs. GMP experience is required
  9. Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment
  10. Strong written and communication skills; and an ability to work effectively with a diverse team of co-workers in a dynamic environment
  11. Positive, adaptable, can-do attitude with quick learning ability
  12. Ability to travel (up to 20%) and work flexible hours, as required.

WORK ENVIRONMENT:

Employee frequently works in a professional office environment and lab with lots of computer/lab equipment, tools, and moderate amounts of noise and activity.  Employee may occasionally be required to travel.  The work environment is fast-paced and demanding. Off-shift, weekend and overtime duties may be required as assigned by the manager.

Kura Oncology offers an attractive salary and benefits package, including equity incentives. To apply, please submit your resume to careers@kuraoncology.com

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San Diego, CA 92121

Cambridge, MA 02142

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

Disclaimer: The information you have requested is not provided by Kura Oncology but by a third party and is not intended to be relied on for investment purposes. Kura Oncology does not guarantee the accuracy or completeness of this information and is not liable for any delays, inaccuracies, errors in, or omissions of any such information, or for any actions taken in reliance on this information, or for any damages arising therefrom

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Posted on

Type

Executive / senior industry position

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San Diego , United States