We are Mirati
Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.
- Work with multi-functional project teams to design and execute phase-appropriate analytical strategies including analytical method development and qualification/validation, establishment of specifications, reference standard characterization, and product characterization.
- Manage activities related to analytical method development, optimization, troubleshooting, qualification, and validation activities for starting materials, process intermediates, drug substances, and drug products internally and across CMOs.
- Identify and recommend analytical methodologies to support chemical development, formulation development, QC and stability testing.
- Manage analytical activities at CROs/CMOs including method development and qualification/validation, and characterization testing. Ensure studies are conducted in compliance with GLP and cGMP regulations, as applicable.
- Provide guidance in the resolution of technical issues, review deviation events and failure investigations at contractor sites in coordination with internal and external quality control, quality assurance, and regulatory groups, as appropriate. Provide technical input for OOS and OOT investigations.
- Author/review analytical sections of chemistry, manufacturing and control (CMC) sections of regulatory submissions.
- Author/review technical documents outlining analytical activities including method validation, reference standard and impurity characterization, stability.
- Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.
- Represent analytical function in CMC teams and interdepartmental meetings.
What is Required:
- Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 15+ years of relevant industrial experience, or BS +18 or more experience
- Experience with analytical development of small molecules, solid oral and parenteral formulations in various stages of development (preclinical to Phase 3)
- Extensive analytical method development, troubleshooting, and validation experience
- In-depth experience with the development and validation of analytical methods (HPLC, GC, dissolution, compendial methods, etc), identification of impurities and degradation products, reference standard qualification.
- Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC for development and commercial stage programs
- Working knowledge of GLP and cGMP, worldwide regulatory requirements, and current industry practices
- Experience preparing and updating regulatory filings (IND, NDA, MAA)
- Outstanding written and verbal communication skills
- Ability to effectively organize and prioritize tasks to achieve established deadlines
- Ability to multi-task and good adapt rapidly to changing business requirements in a dynamic corporate environment
- Proven problem-solving skills are a must
- Ability to travel up to 25% domestically and internationally