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Associate Director/Director, Process Engineering and Validation

3 months ago

San Diego, United States Kura Oncology, Inc. Full time

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 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 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 www.kuraoncology.com . 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. Are you open to considering relocation to Boston? -- Are you open to considering relocation to San Diego? -- Will you now or in the future require sponsorship for employment to work in the United States?

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