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Vertex Pharmaceuticals Incorporated

Material Operations Senior Manager

Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, us, 02298


Job DescriptionBiopharma CGT (Cell and Gene Therapies) is seeking a Senior Manager of Materials Operations to lead a team responsible for multiple GMP warehouses within Vertex's internal Cell and Gene Therapy manufacturing network. This role will be accountable for operations of the Just in Time (JIT) warehouse in the new cell and gene manufacturing facility in Boston's Seaport district and similar operations in the CAM and VMC (Vertex Manufacturing Center) MFG facility. The Sr Manager also manages the outsource central services function that manages material movement and wipes down into the manufacturing facility. The position will report to the Associate Director of Site Supply Chain.Key Duties and Responsibilities:Act as Business Process Owner for materials operations, collaborating with other Material operations leads within the network, aligning on processes and system needs.Responsible for all aspects of warehouse and materials operations functions for the GMP/non-GMP materials within the greater Boston area warehouses from receipt through delivery to the manufacturing floor.Develop and oversee execution in compliance with governing regulations, policy and procedures related to storage and transport and delivery of GMP materials to the manufacturing organization.Maintain loading dock, GMP warehouse and various staging space, assuming full responsibility for material handling equipment ordering, installation, cleanliness, and maintenance.Work with key partners Mfg, PD, AD, QC, QA, Lab Management and others as assigned to ensure compliant processes for all materials operation's needs.Maintain accurate inventory and material controls.Own the material flow strategy for CGT LC1 and other facilities as assigned.Manage the team that transfers inventory from staging, consumables for GMP cleaning, gowning, and production into the manufacturing suites.Oversee outsourced function for central services.Manage the flow and staging of incoming raw materials, gowning, cleaning reagents and supplies.Own and drive CAPA (Corrective Action and Preventive Action) actions for cleanroom operations improvements and corrections.Participate in compliance and EHS audits and own responses/actions.Lead MES and MFG batch creation processes, move orders, and all Oracle transactions.Other duties and projects as assigned to meet departmental requirements.Knowledge and Skills:College Degree (Bachelor's degree in business, Material Operations Management, or related field) and requires 5 years of experience working within a cGMP material operations environment and/or with GCP regulations.Experienced team leader, self-directed and organized.Previous experience in some or all of the following: GMP Manufacturing support, Logistics, Distribution, Warehousing, and Material Operations.In depth knowledge of warehouse operations in a GMP as well as a non-GMP setting.Knowledge of warehouse and distribution business processes.Strong working knowledge of common ERP systems.Strong knowledge of cGMP requirements for manufacturing.Excellent communication and problem-solving skills.Strong computer skills including Word, Excel, Outlook.Proficient in aseptic technique in cleanrooms up to Grade A.Flex Designation:

On-Site DesignatedFlex Eligibility Status:

In this On-Site designated role, you will 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 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

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