In June 2019, Vertex announced the establishment of 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 mular 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.
This role will be responsible for the creation and revision, as well as review and approval of master data within the LabVantage Laboratory Information Management System (LIMS) implemented at the Vertex Cell and Gene Therapy sites. This position will be responsible for providing end-user support for all analytical groups as well as compliance to global Vertex internal policies and procedures. Additionally, the LIMS Master Data Coordinator may be tasked to participate in a global process for general or Vertex Global applicable master data creation, revision, and review.Responsibilities:
- Support QC, AD and PD departments in the build and/or revision, review and approval of master data, including but not limited to products, specifications, and methods in LIMS, per global and local LIMS procedures.
- First-line support for end-user LIMS template and data entry issues.
- Assist in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing of master data at the VCGT Cambridge, Providence and Watertown facilities.
- Assist in the development and implementation of a site process for the scheduling and status tracking of all site LIMS Master Data, including needs for Raw Material, Finished Product, and Stability testing.
- Work with the site LIMS Administrator to maintain site and Catalent Global requirements of LIMS.
- Participate in the development and/or revision of VCGT Standard Operating Procedures.
- LIMS Report Generation per area requirement
- System/Process auditing to ensure data is current in both
- Bachelor's degree from four-year college or university in any of the following disciplines: Pharmacy, Biology, Chemistry, Engineering, Information Technology or related discipline
- 4-6+ years of related experience preferably in the Pharmaceutical or Biotech industry or relevant business experience. Experience with LIMS or Material Management System
- Possesses the knowledge and ability to apply basic scientific and regulatory principles to solve operational, as well as routine quality tasks.