Associate Director, Analytical Development
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:
- Serve as the subject matter expert and lead all aspects of analytical activities to support development of drug substances and drug products at CRO/CMO: method development, method validation/transfer, release and stability testing, characterization of raw materials, reference standards, reference materials, Intermediates, and APIs & DPs.
- Provide analytical support to formulation development, drug substance and drug product manufacturing process development.
- Provide technical input in OOS, OOT, anomalous results investigation, identify root cause.
- 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.
- Participate and contribute to setting specifications for drug substance and products, regulatory starting materials, intermediates, and raw materials.
- Analytical lead for multiple programs responsible for end-to-end aspects of the product and process. Lead development and implementation of analytical strategies for various development stage projects to achieve optimal results.
- Provide input to department budget and resource allocations, run resource forecasting, and conduct & control expenditures against the department budget to ensure projects and initiatives are completed on time within budget.
- Leads scientific innovation efforts to identify, evaluate and implement novel technologies while providing technical expertise during audits of testing laboratories and traveling to CRO/CMO 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.
- Ensure timely preparations, review and approval of technical reports and documents to support regulatory submissions.
.JOB SPECIFICATIONS:
- BS/MS/Ph.D. degree in chemistry or pharmaceutics or equivalent
- 10+ years for BS/MS or 8+ years for Ph.D. of relevant working experience in analytical development in pharmaceutical industry
- Good understanding of cGLP/cGMP principles, ICH guidelines and past experience in analytical development for new drugs.
- Hands-on experience working with United States Pharmacopeia (USP), European Pharmacopeia (EP).
- Extensive analytical development background and hands on experiences with working knowledge of chemistry, analytical and pharmaceutical science.
- Detail-oriented. Ability to critically evaluate analytical data from a broad range of scientific disciplines.
- Hands-on approach with a strategic and operational focus; capable decision-maker in the execution of responsibilities with a high degree of flexibility to adapt to company and industry changes.
- Outstanding communicator: direct, effective, clear, concise, well organized, and appropriate with shown problem-solving abilities.
- Have both broad and in-depth knowledge as well as hands-on experience in modern analytical chemistry techniques. Outstanding problem-solving abilities.
- Excellent interpersonal/ organizational skills and the ability to multi-task.
- Strong leadership and collaboration skills
- Ability to thrive in a highly entrepreneurial, fast paced, and capital efficient environment
- Positive, adaptable, can-do attitude with quick learning ability
- Ability to travel and work flexible hours, as required.
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
- 14 Holidays + 3 Floater Holidays (Including 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
- Cell Phone and Wellness Stiped
- 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 Tipifarnib and ziftomenib. Tipifarnib is a farnesyl transferase inhibitor that recently received Breakthrough Therapy Designation (BTD) for the treatment of patients with certain head and neck cancers that carry HRAS mutations. Tipifarnib will also be evaluated in combination with an inhibitor of PI3Kalpha to treat between 20-50% of patients with HNSCC, the 7th largest cancer worldwide. ziftomenib is an inhibitor of the menin/MLL interaction, which is are critically important for survival, growth, and proliferation leukemic blasts. Kura recently presented preliminary clinical data for ziftomenib at the 2020 American Society of Hematology (ASH) meeting that demonstrated that it demonstrates favorable safety and tolerability and compelling evidence of activity in genetically defined AML patients.
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.
Date Posted
09/27/2022
Views
17
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