Companies you'll love to work for

Job Description

General Summary:

This role provides oversight and management of the commercial stability program within the Material Science and Technology – Quality Control department (MS&T- QC). This role is responsible for managing the commercial stability team across small molecule and cell and gene modalities. Responsibilities include ensuring processes are executed in a compliant manner, improving processes to reduce complexity and increase efficiency, fostering good relationships with internal and external stakeholders, and living Vertex’s vision and values. The role has formal people management responsibilities.

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

Key Duties and Responsibilities:

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

• Oversee the commercial stability program, which encompasses all commercial products/strengths including starting materials, drug substance intermediates, drug substance, critical components, drug product intermediates, and drug products
• Improve on all stability program sub-processes to ensure compliance and efficiency
• Effectively communicate with internal and external stakeholders
• Ensure stability studies are initiated within project timelines and proactively monitor studies to ensure compliance with study protocols, quality agreements and regulatory commitments
• Review OOS/OOE investigations and laboratory deviations and assess change controls for impacts to the stability program
• Perform data analysis and trending according to industry guidelines
• Generate and provide stability reports for submission to regulatory authorities
• Monitor and react to key process performance indicators (KPI).
• Author and review SOPs, protocols, and reports
• Ensure team’s flexibility to accommodate changing timelines and priorities
• Manages other staff ensuring compliance of team with all relevant regulations and SOPs
• Professionally develop team through goal setting, individual development plans, and continuous learning
• Identifies areas for improvement and drives projects to implement solutions.
• Interacts and supports regulatory agency responses and audit requests

Key Qualifications:

• 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 analytical methodologies such as chromatography, dissolution, and Karl Fisher and applying/interpretation of GMP requirements
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
• Experience in building and growing an organization into a high-performance team.
• Effective communication skills, both verbal and written.

Education and Experience:

• 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 7+ years, or Bachelor's and 10+ years in pharmaceutical/biopharmaceutical industry and 2+ years of management experience.

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 ApplicationAssistance@vrtx.com