QC Stability Manager

Job Description

This role manages daily operations that occur in the commercial stability program within the Manufacturing Science and Technology – Quality Control department (MS&T- QC), supporting multiple modalities including Cell and Gene Therapies, small and large molecule programs. Responsibilities include ensuring stability testing is executed in a compliant manner at CDMOs, trending data to assess regulatory commitments and inform regulatory strategy, and ensuring annual commitments are stationed. This role will partner with cross-functional teams (including Quality Assurance, Analytical Development, Analytical Sciences and Technology, and Supply Chain) to ensure product quality, safety, and efficiency.

This position reports directly to the: Senior Manager of MS&T-QC

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Manage commercial stability products, which encompasses all starting materials, drug substance intermediates, drug substance, critical components, drug product intermediates, and drug products for a commercial program
• Serves as MSAT-QC representative in cross-functional working teams and/or working with outside vendors to meet commercial stability needs
• Ensure stability studies are initiated within project timelines and proactively monitor studies to ensure compliance with study protocols, quality agreements and regulatory commitments
• Perform data analysis and trending according to industry guidelines
• Generate and provide stability reports for submission to regulatory authorities
• Authors, reviews, and/or approve data and trending reports
• Identifies areas for improvement and drives projects to implement solutions.
• Effectively communicate with internal and external stakeholders
• Monitor, track and publish commercial stability program metrics 
• Ensure all records adhere to cGMP/GDP expectations 
• Monitor and react to key process performance indicators (KPI).

Minimum qualifications:

• Bachelor's Degree in science or related discipline is required.
• Typically requires the following or the equivalent combination of education and experience: Master's and 5+ years, or Bachelor's and 8+ years in pharmaceutical/biopharmaceutical industry
• Experience with commercial stability programs.
• Experience with statistical software and its application to support commercial stability
• Knowledge of US and EU cGMP regulations/guidance.
• Knowledge of cell and gene therapy assays including UV-spectroscopy, microscopy, and flow cytometry; knowledge of analytical methodologies such as chromatography, dissolution, Karl Fisher.
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
• Effective communication skills, both verbal and written.

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [email protected]