Sr Mgr/Assoc Dir, Drug Product Development & Manufacturing
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
- Act as drug product technical lead for small molecule programs
- Develop strategies and oversee the execution of activities associated with solid oral drug product development and manufacturing, supporting clinical development and subsequent commercialization.
- Define and develop appropriate primary packaging for the finished drug product as needed.
- Oversee and manage contract manufacture organization (CMO) to prepare manufacturing batch records, product development reports and other development-related documents.
- Provide Person-In-Plant (PIP) support at CMOs as needed
- Represent the drug product development function at team meetings and sub-team meetings with Clinical Pharmacology, Quality Assurance, and Regulatory Affairs.
- 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.
- Responsible for drug product budget recommendations and management of associated expenses.
Job Requirements
- BA/BS or equivalent years of experience in pharmaceutical sciences or related field.
- 7+ years of relevant industry experience in formulation/process development.
- In depth knowledge and hands on experience on formulation and process development of small molecule oral drug products.
- Manufacturing experience is strongly preferred.
- Late-stage development and commercialization experience is a plus.
- Thorough understanding of cGMP compliance and ICH guidelines
- Demonstrated experience with managing outsourced projects with CMO's.
- 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.
- Travel is various CMOs as required (<15%)
The base range for a Senior Manager is $131,000 - $170,000 and an Associate Director is $166,000 - $191,000 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 atwww.kuraoncology.comand follow us onXandLinkedIn.
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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