Job Description

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 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.

Responsibilities:

• Design, execute and analyze studies to develop and qualify test methods, demonstrate technological feasibility and characterize material and assembled device products, employing multiple analytical methods (e.g. FTIR, DSC, TGA, mechanical tests for hardness, viscosity, chromatography and material stress/strain characteristics)
• As required, lead team in execution of key project activities.
• Enable transfer of assays to QC and provide SME support for assay qualification, author transfer/qualification protocols and reports
• Execute test methods in support of device Process Development and Quality activities
• Troubleshoot, optimize, and trend assay and process performance
• Support the management of third party vendors/CRO's
• Report on project progress, write analytical development protocols and reports, provide recommendations to management
• Identify, qualify, and manage analytical reagents as per regulatory standards
• Establish design criteria using Design of Experiments (DOE) and other contemporary development tools
• Perform sufficient statistical analysis to establish specificity, sensitivity, linear range, precision and accuracy of test methods.
• Establish reference standard materials as required to support assay validation.
• Contribute to regulatory submission documents with detailed method descriptions and data analysis.
• Ensure the accuracy and integrity of analytical data generated.
• Maintain excellent written documentation and review (e.g. lab notebook and test forms).

Education level and/or relevant experience(s)

Required:
PhD in Materials Science, Analytical Chemistry, Biomedical engineering, Polymer Chemistry or related discipline with 2+ years of relevant industry experience in assay/analytical development.

Or Masters in Materials Science, Analytical Chemistry, Biomedical engineering, Polymer Chemistry or related discipline and significant demonstrated industry experience in assay/analytical development.

Preferred:

• 2+ years of relevant pharmaceutical industry experience in medical devices.
• Additional experience in the cell and gene therapy space optimal.

Knowledge and skills (general and technical)

Required:

• Hands-on experience with the following methods: FTIR, TGA, DSC, porosity/flux, and mechanical material characterization (e.g. hardness, viscosity, stress/strain curves). GC/LC method development also desirable.
• Project or people management experience in relevant area of development.
• Expertise in development and validation of analytical methods.
• Demonstrated leadership with method transfer between sites or a CRO/CMO
• Ability to use literature to design proof of concept experiments for new assays
• Experience with regulatory agency submissions and correspondence
• Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team

Preferred:

• Proven experience with medical device material characterization
• Experience with sample management and ELN/LIMS systems in the GMP environment.
• Background in cell therapy and/or mammalian cell culture and/or metabolic diseases also desirable.

Other Requirements (licenses, certifications, specialized training)

• Authorized to legally work in US
• Flexible team player excited to collaborate with internal and external partners

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Company Information