Manufacturing Science and Technology Senior Scientist

Job Description

General Summary:

The MSAT Senior Scientist provides a critical technical role for the Commercial Manufacturing & Supply Chain, focused on Cell and Gene therapies. Under supervision, the Senior Scientist is responsible for product commercialization activities (PPQ, PLI readiness etc.), post-approval process monitoring (CPV, OOS, OOT and Deviation handling), change management and support of process related investigations.

Key Duties and Responsibilities:

• Develops timelines, communicated with key stakeholders, to ensure MSAT activities are prioritized and executed to meet the requirements of the program. Contributes to cross-functional teams (VCGT, External Manufacturing, Supply Chain, and Quality functions) to ensure that process validation, technology transfer, deviation management, process monitoring and post-approval change management are managed within agreed processed and are on target.
• Resolves issues independently, where possible, and escalates other risks appropriately.
• Partner effectively and manage relationships with external CDMOs and key suppliers to meet manufacturing and program goals.
• Through the development of process data driven reports, support compliance and efficiency related projects working towards the goal of continuous improvement to increase value and efficiency.
• Provide support and applicable manufacturing process related content for CMC regulatory submissions and assist with technical CMC regulatory/Agency questions.
• Actively participates in daily operations related meetings to support manufacturing operations
• Actively participated in supporting Vertex agenda items through the Joint project teams with our CDMO business partners.
• Provides trainings and technical presentations as required.

Knowledge and Skills:

• Strong background in Cell and Gene Therapy pharmaceutical manufacturing processes and technologies.
• Knowledge of current Good Manufacturing Practices (cGMP) and regulatory requirements related to pharmaceutical manufacturing.
• Experience with process development and scale-up of pharmaceutical manufacturing processes, including process optimization, troubleshooting, and validation.
• Experience with statistical analysis (including JMP) for process optimization and validation.
• Excellent communication skills, both verbal and written, with the ability to communicate complex technical information to a range of stakeholders.
• Strong problem-solving and critical thinking skills, with the ability to analyze data and make sound technical recommendations.
• Strong leadership skills to contribute to, and provide technical guidance to, cross-functional teams.
• Travel required: 25% primarily in the EU and some (limited) US travel.

Education and Experience:

• Bachelor's Degree in science or related discipline is required and equivalent experience.
• Significant Experience with process development and technical support of commercial biological products and cGMP manufacturing. Experience with Cell and Gene therapies preferred.
• Knowledge of US and EU cGMP regulations/guidance.
• Experience with technology transfer, process validation and process monitoring.
• Direct experience working with contract manufacturing organizations (CDMO) and/or technical service partners.
• Technical experience supporting manufacturing quality compliance including deviations, change controls and CAPAs

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

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