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Manufacturing Science and Technology Associate Director

Semma Therapeutics

Semma Therapeutics

IT
Boston, MA, USA
Posted on Wednesday, May 22, 2024

Job Description

The Associate Director, Manufacturing Science and Technology (MSAT) – Materials Science will support the Vertex Cell and Gene Therapy (VCGT) manufacturing 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 cell and gene therapies.

Key Responsibilities:

  • Represent the MSAT function in cross-functional teams as a materials science leader for single-use systems, cell culture media, cytokines, and/or small/large molecule raw materials.

  • Support and champion continuous improvement and technical innovation within the VCGT network with respect to raw materials.

  • Establish procedures and business processes to conduct raw material technical assessments, support onboarding new materials and technologies, alternate material sources, as well as supplier-initiated material change notifications.

  • Demonstrates unmistakable intellectual and/or technological leadership on material science projects.

  • Collaborate with risk management and program management functions to articulate technical risks and develop/manage mitigations.

  • Liaise with technical leads from other programs and functions to build collective cell and gene therapy knowledge.

  • Engage industry to identify best practices and improvement opportunities.

Minimal Requirements:

  • Requires 6-8 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 or equivalent is essential.

  • Deep knowledge of cell culture media formulations and manufacturing, single-use-systems, and small/large molecule materials.

  • Previous experience working in a highly matrixed environment.

  • Extensive experience with biologics process development and cGMP manufacturing.

  • Experience with cGMP regulations/guidance and regulatory agency inspections.

  • Experience authoring/reviewing CMC product submissions and post-approval changes.

  • Experience with continuous improvement, proficiency with operational excellence preferred.

  • Experience working with external manufacturing partners (CDMOs), suppliers, and service providers.

  • Ability to travel, nationally and internationally, up to 10%.

  • Flexibility to work on site a minimum of 3 days per week.

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.

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.