|Job Description||Stability Coordinator/Manager|
What is this role really like?
The position will oversee stability activities within the Analytical Development function. He/she will be responsible for the design, implementation, review, and tracking of stability studies as well as stability data trending for development projects, from pre-clinical lead candidate selection through clinical development, registration filings and up to commercialization. He/she will provide guidance on the design of stability studies to support clinical studies and regulatory submissions. He/she will be responsible for authoring the stability sections of regulatory filings. He/she will provide guidance and support to internal groups such as regulatory, quality and manufacturing as well as to outside groups such as contract manufacturing organizations to ensure that stability studies are conducted in compliance with all applicable regulations and corporate policies and procedures (GLP and GMP).
- Develop and recommend stability strategy and study design for drug substance and drug product
- Oversee stability study design, execution, monitoring, reporting, data management (collection and archiving), and data trending and analysis for studies performed at contract service providers
- Provide leadership for stability deviation events, failure investigations, and temperature excursion reports
- Oversee stability testing for development, clinical and commercial materials
- Provide retest period/shelf life recommendations based on available stability data and statistical analysis in accordance with ICH guidelines
- Lead implementation of corrective actions and quality system improvements related to the stability program
- Participate in selection and audits of contract service providers used for stability studies
- Authors stability sections for regulatory filings
- 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 stability function in CMC teams and interdepartmental meetings
- Identify, manage and coordinate outsourcing activities when appropriate
- Serve as primary liaison with outside stability vendors on projects
- Ensure studies are conducted in compliance with GLP and GMP regulations, as applicable
- Assist with Product Quality Trending of release data to support process capability analysis and specification justification
What would a successful candidate look like?
- Doctoral (Ph.D.) or Masters (M.S.) degree in Analytical Chemistry or related discipline plus 5 years of relevant industry experience, or BS +7 years of experience
- Practical experience in scientific discipline and in managing stability studies (2+ years)
- Ability to independently design, conduct and interpret laboratory studies
- Ability to evaluate analytical test results (HPLC, GC, dissolution, compendial methods, etc.)
- Experience preparing and maintaining regulatory filings (IND, NDA, MAA)
- Successful history building and managing analytical stability functions
- Strong 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
Mirati is an Equal Opportunity Employer (EOE) – we celebrate diverse experiences and welcome applicants that meet the minimum requirements. All applicants must be legally authorized to work in the US without sponsorship.
This role is NOT open to agencies- please no emails or phone calls.