Manufacturing Science and Technology Senior Scientist

Job Description

The Senior Scientist, Manufacturing Science and Technology (MSAT) - Biologics is a key role within the Commercial Manufacturing and Supply Chain (CMSC) organization and will be responsible for supporting technical programs within the Vertex Biopharmaceutical Sciences and Manufacturing Operations (BSMO) network. The role, based at the Boston Seaport site, will partner with cross-functional teams internally, and with external partners, to ensure project deliverables supporting product commercialization are met, and clinical and commercial supply to our patients is uninterrupted. The Senior Scientist is responsible for product commercialization activities (PPQ, PLI readiness etc.), post-approval process monitoring (CPV, OOS, OOT and Deviation handling), and change management.

Key Responsibilities:

• Develops timelines and communicates with key stakeholders, to ensure MSAT activities are prioritized and executed to meet project requirements.
• Contributes to cross-functional teams to ensure that projects are appropriately managed and are on target.
• Resolves issues independently and escalates other risks appropriately as needed.
• Partner effectively and manage relationships with external stakeholders and key suppliers to meet goals.
• Through the development of process data driven reports, support compliance and improvement related projects.
• Works towards the goal of continuous improvement to increase value and efficiency.
• Provide support and applicable manufacturing process related content for regulatory submissions and assist with technical regulatory/agency questions.
• Flexibility to work on site a minimum of 3 days per week, with 10% travel expected

Required Experience:

• Requires a minimum 6 years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience.
• Bachelor's degree in science/engineering or equivalent is essential.
• Experience with process development and technical support of commercial biological products and cGMP manufacturing.
• Knowledge of cGMP regulations/guidance across major health authority regions.
• Experience with technology transfer, process validation and process monitoring.
• Direct experience working with contract manufacturing organizations 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