Senior Manager/ Associate Director, Stability
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:
- 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 CDMO-generated stability protocols, stability reports and associated raw data records within agreed time frame.
- Enter all related stability 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 CDMOs and provide technical input on stability-related investigations (OOE, OOS, etc.) to ensure each investigation is conducted and completed per appliable 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.
- Ensure timely preparations, review and approval of technical reports and documents to support regulatory submissions.
- Author and review CMC sections for regulatory submissions. Review, prepare and deliver technical documents for regulatory submissions.
- Author and review relevant CMC SOP(s) as needed.
- Leads scientific innovation efforts to identify, evaluate and implement novel technologies while providing technical expertise during audits of testing laboratories and traveling to CRO/CDMO and testing laboratories as needed.
- Interacts and collaborates related functions and cross-functionally (Development, Regulatory, Quality, Clinical, contract manufacturing).
- Independently apply technical and management expertise to meet goals, timelines and make technical and management decisions to keep projects on track.
- Manage reference standards including reference standard inventory management at central location and CDMOs, reference standard retest, reference standard shipment to CDMOs and clinical trial sites.
JOB SPECIFICATIONS:
- BS/MS degree in chemistry or pharmaceutics or equivalent.
- 7+ 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 ability to work effectively with a diverse team of co-workers in a dynamic environment.
The base range for a Senior Manager is $131,653 - $165,911 per year. The base range for an Associate Director is $156,060 - 183,425. 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 www.kuraoncology.com.Â
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.Â
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Date Posted
09/07/2023
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21
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