Stability Manager

MS or BS with minimum of 8 years of industry experience in Pharma / Biotech industry required.

Other combinations of education and/or experience may be considered.

Strong understanding of vaccine stability principles, including degradation pathways, accelerated stability testing, and shelf-life determination.

Demonstrated proficiency and expertise in various analytical methodologies, particularly in the context of stability testing and assessment of biologics or vaccines.

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.

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.

The compensation package will be competitive and includes comprehensive benefits and an equity component.

$147,000 – $171,000 *(SF Bay Area). Salary ranges for non-California locations may vary.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Designs, coordinate, and execute stability studies for early and late-stage vaccine products according to regulatory guidelines and company protocols.

Summarize vaccine stability results by applying analytical testing expertise to ensure scientific and technical excellence. Utilize statistical software like JMP to perform rigorous statistical analyses, ensuring robust interpretation of data and adherence to regulatory standards.

This includes, but not limited to, creating, implementing, and managing stability databases, performing data trending and statistical analysis, study and testing 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.

Produce impactful PowerPoint presentations to effectively communicate stability data to diverse project team members. Support the attainment of project milestones by facilitating stability monitoring and determining expiration dates for clinical and in-process materials.

Authors, reviews, revises, and approves SOP's, stability protocols and reports, memo’s, regulatory and specification documents (as required).

The Stability Manager will also assist with leading the functionality and maintenance of stability related processes and systems.