About the job Manager/Senior Manager, Stability
We’re looking for an Manager or Senior Manager, Stability to join the Analytical Development group. This position reports to the Director, Analytical Development. This is a newly created position due to company growth.
ESSENTIAL JOB FUNCTIONS
- Manage all development and GMP stability studies for pipeline projects, including those for regulatory starting materials, intermediates, drug substances and drug products, and maintain the stability schedule for each study.
- Propose appropriate stability study design per material and project needs, review and approve CMO-generated stability protocols, stability reports and associated raw data records within agreed time frame.
- Enter all related stability and SOP documentation into EDMS and manage document control aspects for stability and related QC elements.
- Coordinate with Quality Assurance to establish retesting and expiration periods and change controls for all specification documents for drug substance, drug product, and clinical trial materials as subject matter expert.
- Coordinate with CMOs and provide technical input on stability-related investigations (OOE, OOS, etc.) to ensure each investigation is conducted and completed per applicable SOPs.
- Perform stability trending analysis and keep CMC team updated on study status and issues.
- Assign and document retest period or expiry date based on available stability data and applicable guidelines.
- Assemble stability data tables, write the stability sections, and contribute to the reviews for regulatory submissions.
- Contribute to setting specifications for drug substance and products, regulatory starting materials, intermediates, and raw materials.
JOB REQUIREMENTS
- BS/MS degree in chemistry or pharmaceutics or equivalent.
- 5+ years of relevant working experience in analytical development in pharmaceutical industry.
- Good understanding of cGLP/cGMP principles and ICH guidelines.
- Extensive analytical development background and hands on experiences with working knowledge of chemistry, analytical and pharmaceutical science.
- Working knowledge of EDMS quality systems such as Veeva Vault.
- Detail-oriented and ability to critically evaluate analytical data from a broad range of scientific disciplines.
- Have both broad and in-depth knowledge as well as hands-on experience in modern analytical chemistry techniques. Outstanding problem-solving abilities.
- Strong leadership, teamwork, organization, 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.