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.