Senior Director, Analytical Development - Late Stage
Department: Technical Operations / CMC
Employment Type: Full Time
Reference Number: 1607504
Job Description Summary
The position will report to the head of Analytical Development and will be responsible for the development of analytical methodology and characterization activities in support of a late stage development program. He/she will provide guidance and support to internal and external groups to ensure that products are manufactured in compliance with all applicable regulations and corporate policies and procedures (GLP and cGMP). He/she will provide analytical support for drug substance and drug product manufacture in support of preclinical, clinical, registrational, and commercial batches.
- Lead analytical activities for one late-stage development program. Interface 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.
- Develop strategy for method alignment at multiple manufacturing sites for drug substance and drug product.
- Perform trending of product quality attributes for one program, including but not limited to: release and stability data trending, impurity tracking and identification, and impurity qualification.
- Help develop and implement global systems and tools to improve efficiency in the Analytical Development group. Generation of guidelines and SOPs to standardize tasks within Analytical Development. Work with IT to implement analytical software.
- 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.
- Oversight of GMP testing activities and lab operations pertaining to the specific program. 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 pharmaceutical industry experience, or BS +18 or more experience
- Hands-on experience with analytical development of small molecules and solid oral formulations during late stage development (Phase 2 to commercial)
- Demonstrated knowledge of drug development, CMO management, manufacturing, and regulatory CMC for development and commercial stage programs
- 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.
- 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
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.