Senior Manager, Process Research Chemistry

Kura Oncology

Job Description

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.

ESSENTIAL JOB FUNCTIONS:

  • Independently design synthetic strategies and routes to target molecules.
  • Conduct Process Research and early phase Development, and successfully manage API Process Research programs.
  • Identify and develop cost-efficient, scalable, and robust drug substance manufacturing processes.
  • Establish drug substance Research and Development strategies suitable for technology transfer and scale-up including the related raw material and intermediate synthesis.
  • Provide strategic planning as well as technical support and manage contract research and development organizations (CRO/CDMO's) to identify and prepare new manufacturing routes, comprehensive research and development reports and other development-related documentation.
  • Guide external third parties through technology transfer, process development, optimization, qualification, and validation of the activities related to DS manufacturing operations.
  • Travel to be on-site at CRO's, as necessary.
  • Collaborate with other Kura functions and departments to assure compliance with applicable GMP and global regulatory requirements.
  • Author and review of CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs).
  • Provide expert technical strategic support and documentation for answering questions during regulatory submission reviews.

JOB SPECIFICATIONS:

  • Ph.D. in synthetic organic chemistry or synthetic methodology development.
  • A minimum of 5 years' industry experience after post-doctoral experience in process research ideation and route identification with demonstrated publication record in organic process research is required.
  • Excellent planning and organizational skills in managing a process research program at CRO's.
  • Experience with managing outsourced projects with CRO contractors.
  • Strong leadership, teamwork, and collaboration skills.
  • Able to make international and domestic travels.
  • Working knowledge of cGMP requirements and ICH guidelines relating to drug substance process development and manufacture for early development.
  • Knowledge of late development activities such as process registration, validation, and launch, a plus.
  • 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 base range for a Senior Manager is $150,000 - $165,000 per year. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training. Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus.

Kura's Values that are used for candidate selection and performance assessments:

  • We work as one for patients
  • We are goal-focused and deliver with excellence
  • We are science-driven courageous innovators
  • We strive to bring out the best in each other and ourselves

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
  • 18 Holidays (Including Summer & Winter Break)
  • 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
  • Lifestyle Spending 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 three investigational drug candidates: ziftomenib, tipifarnib and KO-2806. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Ziftomenib is currently enrolling patients in a Phase 2 registration-directed trial (KOMET-001) in NPM1-mutant relapsed or refractory AML. Kura is preparing to initiate multiple Phase 1 trials to evaluate ziftomenib in combination with current standards of care in earlier lines of therapy and across multiple patient populations, including NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial (KURRENT-HN) in combination with alpelisib for patients with PIK3CA-dependent HNSCC. Kura intends to evaluate KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial (FIT-001) as a monotherapy and in combination with other targeted therapies in adult patients with advanced solid tumors. For additional information, please visit Kura's website at .

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.

 

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