Director, Manufacturing Operations - MSAT Devices
Semma Therapeutics
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General/Position Summary
This role enables the commercial manufacturing of combination devices to support our ongoing programs. They will support the implementation of commercially capable processes for manufacturing. S/he will understand device manufacturing, including working with device development and clinical manufacturing to enable commercial manufacturing at various scales. This role will report to the Sr Director of Manufacturing Operation - Devices within the MSAT Organization
Key Duties & Responsibilities
Work with colleagues across Vertex, including Process Development and Vertex Cell and Gene Therapy, Device Groups, Pharmaceutical Sciences, Packaging, and Commercial to bridge device manufacturing technology from development into commercialization and commercial manufacturing.
Work with contract development and manufacturing organizations (CDMOs) on tech transfer, process installation, qualification, and ongoing manufacturing oversight of regenerative medical devices.
Ensuring ongoing technical support is supplied for all manufacturing processes internally and/or at contract manufacturing sites and directing global initiatives and cross-functional teams of subject matter experts in manufacturing.
Ensuring ongoing support for combination device development programs during various stages of the programs lifecycle.
Provides visible leadership in one or more technical areas.
Assists in the creation of department goals.
Partner with late-stage product development teams and contribute to regulatory filing activities to ensure the robustness of the commercial manufacturing process.
Develops and executes manufacturing strategies for Technology Transfers and Process Validations, including formulating strategic master plans, protocols, and reports.
Coordinates activities and leverages best practices across multiple projects and suppliers.
Champions high-impact cross-functional initiatives and maintains strong relationships with key internal and external stakeholders.
Evaluates process performance using statistical process controls to identify and lead continuous improvement activities throughout the product lifecycle.
Drives resolution of complex manufacturing issues and leads global expansion activities throughout the product lifecycle.
Directly supervises one or more individuals. Recruits, directs, motivates, and develops staff, maximizing their contribution, professional growth, and ability to function effectively with their colleagues.
Required Education Level
BS or MS or PhD in engineering or another relevant discipline. BS and 11+ years of experience (9+ years with Masters, 7+ years with PhD) working on process development and optimization within a medical device environment or other GMP-regulated industry.
Required Experience
Provides visible leadership in one or more technical areas.
Assists in the creation of department goals.
Partner with late-stage product development teams and contribute to regulatory filing activities to ensure the robustness of the commercial manufacturing process.
Develops and executes manufacturing strategies for Technology Transfers and Process Validations, including formulating strategic master plans, protocols, and reports.
Coordinates activities and leverages best practices across multiple projects and suppliers.
Champions high-impact cross-functional initiatives and maintains strong relationships with key internal and external stakeholders.
Evaluates process performance using statistical process controls to identify and lead continuous improvement activities throughout the product lifecycle.
Drives resolution of complex manufacturing issues and leads global expansion activities throughout the product lifecycle.
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.
This job is no longer accepting applications
See open jobs at Semma Therapeutics.See open jobs similar to "Director, Manufacturing Operations - MSAT Devices" F-Prime Capital Partners.