Manager/Sr. Manager of Stability QC
San Carlos, CA
We are looking for an energetic and talented individual to join our Vaccine Product Development organization as a Manager/Sr. Manager of Stability within Quality Control Unit. The primary function of this level position is to manage the stability program for various projects in preclinical and clinical development. This position reports directly to the Director of Stability.
The position will be an integral part of the team implementing and maintaining cGMP Stability for all phases of clinical development. Primary responsibility will include managing stability studies for individual projects and stability data analysis. This individual will collaborate with QC members in a highly collaborative and cross-functional environment. The ideal candidate will apply strong stability experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches.
- Manage and coordinate stability studies on development and clinical lots, summarize stability results to ensure scientific and technical excellence. Perform statistical analyses using statistical software's such as JMP.
- This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, forecasting and reporting of metrics, creation, revision and approval of SOP's, stability protocols and reports in accordance with current GMP, FDA, EU, Global and ICH guidelines and regulations.
- Effectively disseminate stability data to various project team members, support the achievement of project milestones with regards to stability monitoring and derivation of expiration dates of clinical and in-process materials.
- The QC Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems.
- Drives and inspires team to foster an environment focused on continuous improvement activities for the clinical stability programs.
- Authors, reviews, revises, and approves SOP's, stability protocols and reports, specification documents (as required).
- Facilitates and executes stability study protocol strategy and design including calculation and execution of stability study set downs and pulls both independently and through direct collaboration with key cross-functional teams.
- Ensures that the GMP stability program continuously aligns with FDA, ICH and other international agencies.
- Authors, reviews, and approves supporting memos and reports including those for expiry, interim/final stability reports and Annual Product Quality Reports.
- Manages Quality Systems records for QC Stability- creates, assesses, reviews Deviations, Change Controls, CAPA's and other applicable stability-related investigations and events.
- Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions.
- Provide strong teamwork in establishing a quality culture and shared accountability. Ensure GMP compliance is built into the design and implementation of processes and systems, including tracking metrics to monitor and improve performance.
- MS or BS with 5-10 years of industry experience in Pharma / Biotech industry required.
- Solid understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to stability study design, expiry dating, and analytical method qualification/validation for biologics and vaccines.
- Strong understanding of various analytical chemistry methodology principles, and track record of validation for GMP release and stability testing, and stability trouble shooting.
- Solid understanding and hands-on experience of applying basic statistical tools for stability data trending and rate analysis to support retest period/ shelf-life proposals is preferred.
- Experience in IND, NDA and BLA submission is highly preferred.
- Experience working in a regulated (GLP / GMP) environment.
- Attention to detail and excellent skills in record keeping / documentation.
- Extensive technical writing experience.
- Project management skills including the ability to manage one's project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.
- Strong interpersonal skills: ability to communicate effectively both verbally and in written formats.
- Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tactics.
- Ability to work globally with CMOs in different countries and continents.