Position Code: 23073-19R
The Sr. Manager Stability in Analytical Sciences is responsible for managing all aspects of the stability program across all projects, including initiating and managing stability studies, protocol development and maintenance, data monitoring, trending and reporting. This position is responsible to work with the CMC analytical project leader to identify CROs with suitable for capabilities and capacity for contract testing based on the phase of development, to include developmental and registrational stability. The position directly interfaces with the CMC project team including QA and RA.
- Collaborates with project teams to define stability commitments for study design, testing requirements and stability specifications, as appropriate.
- Creates, reviews and/or approves stability study protocols.
- Calculates sample quantities required for testing and the number of samples required per study.
- Administers the stability database, organizes and maintains all stability protocols, files and associated data for all programs.
- Maintains schedule of stability pulls, testing timelines, and reporting deadlines at CMO/CROs and ensures timely pulls per protocol.
- Ensure any stability issues or potential issues are communicated to the appropriate stakeholders.
- Review stability data tables for compliance and trends. Performs expiry dating calculations to identify adverse trends.
- Determine expiry/retest periods for CTM, API, Reference Standards and other materials
- Coordinate with project teams for retesting activities
- Monitor and trend stability data to ensure assigned product shelf life is appropriate and justified.
- Prepares accurate stability summary reports for CMC regulatory submissions, annual reports, and periodic updates to RA or QA.
- Remain current with regulatory and industry requirements relevant to the stability program.
- Updates SOP’s affecting stability requirements to ensure compliance and conformance with current practice and quality systems.
- Supports stability- related investigations.
- Supports completion of Quality audit responses via any related updates to reported stability data, summaries, SOPs or other corrective action required.
Experience & Education
- A minimum of a Bachelor’s degree in scientific discipline.
- 6+ years in analytical development and quality control function in a GLP/GMP or FDA regulated environment.
- Proficient in cGMP’s and pharmaceutical industry procedures and regulations.
- Experience with JMP, SlimStat and/or other statistical/predictive software/applications
- Strong interpersonal, oral and written communication
- Database administration experience
- Demonstrated knowledge of quality systems
- Previous stability management and analytical data review experience highly desired
Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment.
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest to [email protected].