Manufacturing Science & Technology Principal Scientist, Material Science

Job Description

MSAT Principal Scientist - Materials Science, Vertex Pharmaceuticals (Boston)

The Principal Scientist, Manufacturing Science and Technology (MSAT) - Materials Science will support the Biopharmaceutical Science and Manufacturing Organization (BSMO) network by applying a deep understanding of relationships between materials properties, process conditions, and final product quality. The role will have a proven track record of applying in-depth conceptual knowledge of materials science and engineering principles to materials and improved process understanding, with in-depth knowledge of one or more relevant areas applicable to biologics and cell therapies.

Key Responsibilities:

• Represent the MSAT function in cross-functional teams as a materials science SME for single-use systems, cell culture media, cytokines, and/or small/large molecule raw materials.
• Support the development of key quality attributes of critical raw materials used in Vertex's biologics and cell therapy processes.
• Facilitate the use of key quality attributes of critical raw materials for material control and investigations.
• Drive through partnerships within MSAT the use of data analytics for raw material analysis that includes but is not limited to statistical process control / control charts for CoA attributes, correlation between raw material attributes and process performance etc.
• Support drafting material qualification reports with cross functional teams.
• Support procedures and business processes to conduct raw material technical assessments, onboarding new materials and technologies, alternate material sources, as well as supplier-initiated material change notifications.
• Collaborate with risk management and program management functions to articulate technical risks and develop/manage mitigations.

Minimal Requirements:

• Requires 5-7 years of relevant experience in the biopharmaceutical industry or the equivalent combination of education and experience.
• Advanced degree (MS/ Ph.D./ Eng Doc) in Science/Engineering is preferred.
• Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule and Cell and Gene Therapy (CGT) materials.
• Previous experience working in a highly matrixed environment.
• Extensive experience with biologics and cell therapy process development, and cGMP manufacturing.
• Experience with cGMP regulations/guidance and regulatory agency inspections.
• Experience with continuous improvement, proficiency with operational excellence preferred.
• Experience working with external manufacturing partners (CDMOs), suppliers, and service providers.
• Flexibility to work on site a minimum of 3 days per week.
• Up to 10% travel expected

Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For four years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.vrtx.com.

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