Our client is seeking an experienced QC Stability Program Manager to oversee Stability Programs for a direct hire opportunity located in San Francisco, CA. In this role you will have the exciting and unique opportunity to manage QC stability programs to support clinical development activities across multiple drug modalities. This is a high-profile role that will focus on the oversight of stability management across programs.
- Design, manage, and implement innovative stability programs to support a variety of therapeutic modalities, including viral vectors, antibodies, and siRNA including but not limited to the establishment of stability program SOPs including sample handling and storage, stability protocol and report templates, stability sample management and pull master schedules, stability data trending software, and stability data assessment outputs.
- Serve as SME for stability questions related to critical raw material, regulatory starting materials, drug substance, and drug product. Review and approve stability protocols, reports, and data
- Manage the assessment and documentation of data to support comparability studies, retest periods, shelf life projections, degradation or product handling/shipping studies, trending and trend limits, specification establishment and revisions, and impact analyses
- Author and provide scientific representation of stability in all relevant sections for regulatory submissions and regulatory agency responses
- Work cross-functionally to support other areas of the QC organization, such as assay validation and lifecycle management, and management of contract organizations
- Work collaboratively with program leads, QA, project managers, and systems administrators to communicate stability program timelines and resourcing needs.
- Bachelor's degree in a scientific discipline (Chemistry or Biology preferred)
- Prior experience managing a QC Stability Program in bio-pharmaceutical industry
- Prior experience in Phase 1 and Phase 2 trials
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.