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Materials Management & Planning Manager

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Thursday, February 8, 2024

Job Description

Job Summary:

Vertex has established a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies, and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible.

In this position, you will be responsible for supervising the cGMP JIT warehouse at the Cambridge and Seaport locations in support of process development and clinical production, as well as daily material transfers to other Vertex sites and external locations.

·Key Responsibilities include:

  • Develop optimal material flow between Materials Management and Manufacturing.
  • Manage, lead, and coach a team of warehouse employees. Assign, monitor, and review progress and accuracy of work. Direct efforts and provide technical guidance on complex issues.
  • Ensure all warehouse storage areas are inspection and audit ready. Provide support for Regulatory and Financial audits / inspections. Properly manage deviations, CAPAs, and document revisions. Work effectively with cross functional departments to complete investigations as necessary. Execute materials management goals that align with site readiness priorities, including SOP development, design and implementation of material handling procedures, and operational setup.
  • Demonstrate proficiency in the use of the ERP system (Oracle) and execute real time transactions such as material receipts/issues, inventory reporting, inventory reconciliation/investigations, order shipping confirmations and cycle counting. Ensure accurate inventory is maintained and inventory discrepancies are communicated.
  • Coordinate maintenance of equipment, guiding preventive maintenance and coordinating all necessary repairs.
  • Lead continuous improvement and innovation opportunities within the GMP JIT Warehouse, providing input into broader materials management improvement opportunities. Establish metrics, reports, process documentation, training, and safety records. Promote a culture that strives toward continuous improvement in Environmental, Health and Safety.
  • Develop and oversee execution against all SOPs related to receipt, inspection, storage, and delivery of GMP materials to manufacturing organization. Ensure timely receiving, stocking, picking, issuing, and shipping of materials. Manage incoming samples, and EM plates effectively and per procedure.
  • Partner with cross-functional stakeholders to stock Just-In-Time Warehouse with direct and indirect materials to support the production schedule. Participate in daily operational readiness meetings to ensure readiness.
  • Oversee drug product pack-outs and hand-off to shipping partners.
  • Manage min/max inventory levels, assess expiry, coordinate replenishment, and expedite delivery and release of bulk gases.
  • Oversee day-to-day scheduling and coordination of daily material deliveries to external Vertex sites. Utilize Oracle to complete requests for materials and subsequent deliveries. Ensure materials are shipped in correct conditions.
  • Prepare team for potential future operations, including staging, kitting, and MES implementation.

Minimum Qualifications

  • Bachelors Degree in Business, Supply Chain, Operations Management, or related field or equivalent combination of education and work experience
  • Minimum of 5 years experience working within a cGMP supply chain environment and/or with GCP regulations
  • Strong understanding of storage and shipping of cold chain products in the Biotech/Lifesciences industry and the associated documentation requirements.
  • Knowledge of warehouse and distribution business processes.
  • Strong working knowledge of common ERP systems.
  • Ability to perform the physical demands of the role, including lifting moderately heavy boxes, prolonged standing, pushing gas tanks, etc.
  • Previous experience in Logistics, Warehousing, and Supply Chain
  • In depth knowledge of warehouse operations in a GMP as well as a non-GMP setting.

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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.