Associate Director/Director, Process Engineering and Validation

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

• Responsible for leading the engineering aspects and oversight of process development, and process validation elements for successful scale-up of chemical manufacturing processes and drug product manufacturing processes.
• Establish criteria to ensure processes are scalable and robust for drug substance manufacture (including the related raw materials and intermediates) and the routes and strategies are suitable for commercialization.
• Establish, review, and support process validation DOE strategies and evaluations to verify drug product processes are scalable and robust for validation and commercial launch.
• Participate in the design of synthetic processes to target molecules (including RSMs and intermediates) to develop cost-efficient, scalable and robust drug substance manufacturing processes.
• Provide strategic planning as well as technical support and management for contract manufacturing organization (CDMO's) to prepare manufacturing batches.
• Review and approve associated development reports and other development-related documents.
• Guide external third parties through technology transfer, process development, optimization, qualification, and validation of the activities related to DS and DP manufacturing operations. Be on-site, as necessary.
• Collaborate with other functions to assure compliance with applicable GMP and global regulatory requirements.
• Author and review of CMC sections for regulatory filings (INDs, IMPDs, NDAs, MAAs).
• Provide technical strategic support and documentation for answering questions during regulatory submission reviews.
  
  

Job Requirements

• BS/MS, or Ph.D. in Chemical Engineering
• A minimum of 10+ years' industry experience in process development and validation of API and/or DP processes as well as CDMO management
• Strong knowledge of cGMP requirements relating to drug substance and drug products
• Strong knowledge of DS/DP process development, manufacture and validation.
• Demonstrated knowledge of late-stage development, process registration, validation, and launch is required
• Excellent planning and organizational skills
• Able to make international and domestic travel
• Thorough understanding of cGMP compliance and ICH guidelines
• Experience with managing outsourced projects with CDMOs and contractors
• Strong leadership, teamwork, 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 base range for Associate Director is $174,000 - 189,000 and Director is $200,000 - $230,000 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 blood cancers and solid tumors. 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, a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction, has received Breakthrough Therapy Designation for the treatment of R/R NPM1-mutant acute myeloid leukemia (AML). Kura has completed enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML (KOMET-001). The Company is also conducting a series of clinical trials to evaluate ziftomenib in combination with current standards of care in newly diagnosed and R/R NPM1-mutant and KMT2A-rearranged AML. Tipifarnib, a potent and selective farnesyl transferase inhibitor (FTI), is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent head and neck squamous cell carcinoma (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with targeted therapies (FIT-001). For additional information, please visit Kura's website at www.kuraoncology.com and follow us on X and LinkedIn.

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.