Job DescriptionThe External Manufacturing Operations Senior Manager is responsible for driving technology transfer projects to completion within the GMP cell processing operations team and for ongoing manufacturing operations during the clinical phase of production. The incumbent will have expertise in cell culture, GMP, and exceptional project management skills. This is a full-time role and will require up to 50% travel, including international travel.In this Hybrid-Eligible role, you can choose to be designated as:Hybrid: work remotely up to two days per week; orOn-Site: work five days per week on-site with ad hoc flexibilityKey Duties and Responsibilities:Oversee and support clinical product manufacturing for cell therapy according to cGMP standardsDrive more efficient technology transfer and final process development at CDMOs by providing direct oversight. Review, revise and approve controlled documentation including SOPs and Batch Records for manufacturingEnsure cGMP compliance through manufacturing oversight, tracking and reporting of KPIs.Manage scheduling of lots in coordination with CDMOs and cross-functional groups. Responsible for oversight of certain Vertex supplied raw materials and key CDMO deliverables to ensure seamless operation of manufacturing activitiesManage team’s projects to achieve department and corporate goals, including managing timelines and leading group meetingsReview contractual documentation and provide critical feedback to ensure fair terms and limit liabilitiesSupport the management of unexpected events, including investigations and CAPA oversightServe as the technical SME for the team, troubleshoots problems independently and provides potential solutionsDemonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise ThinkingOther duties and projects as assign as required to meet departmental requirementsKnowledge and Skills:10 years in a process related science (education may contribute to experience); at least 5 years working in process development and/or manufacturingExcellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systemsDemonstrated proficiency in technical writing and contract reviewExpertise with adherent and suspension cell culture for GMP manufacturingWorking knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)Environment:Works in a cleanroom and office settingMust be able to remain in a stationary position 50% during cleanroom processing activitiesFrequently move about inside the cleanroom to oversee process tasksCompressed gasses and LN2 are used in this process#LI-HybridCompany InformationVertex 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.
