The Materials Data Scientist/Engineer is a member of Materials Science and responsible for assisting in providing knowledge and expertise to ensure that materials performance is aligned with the specific intentions of the user, the regulations that dictate GMP practices and patient safety.This individual will assist in providing materials integrity, accuracy, and consistency across the CBM organizations that are involved in the use and transformation of materials in processes, as a drug product or in contact with the drug product, as raw and ancillary materials and intermediates or in materials selection, specification and source.
This individual will serve on multidisciplinary teams to affect the flow of materials and materials information from client to release for manufacturing.You will contribute to the definition, creation and defense of new materials specifications and participate in the investigation and vetting of their suppliers and manufacturers.You will provide materials data expertise to internal organizations that require assistance in materials selection and compatibility.
The Materials Data Scientist/Engineer will support the raw materials program at the CBM. The individual will be a key member of the materials science team supporting materials data flow throughout the CBM.You will work with members of Process Development, Program Management, Information Technology, Testing and Analytical Services and Quality Control and Regulatory business units.
Primary duties include but are not limited to:
- Supporting the preparation and review of raw materials data, including specifications, testing plans and risk assessments, for the manufacture of C> products.
- Compiling data for the specification, testing and sampling of raw materials.
- Contributing supplier and manufacturer database development for raw materials and consumables.
- Participate in the writing and revise SOPs as it pertains to materials information data.
- Contribute data to protocols and reports for raw material qualification.
- Contribute to creation of routines for the flow of materials data from sources to end users.
- Review manufacturers’ and suppliers’ product specification data and certificates of compliance and analysis for consistency and the materials attributes needed for materials intended uses
Contribute to the writing and revisioning of SOPs as it pertains to data specifying, acceptance, testing strategy and disposition of raw materials
Education & Experience
- Minimum of bachelor’s degree in technical field with preference in chemistry, materials, biological/biopharm science, pharmacy
- Knowledge of in materials/chemical name discrimination and identification
- Knowledge of materials qualities and discernment of test for their attributes
- Ability to author and review protocols, reports, and standard operating procedures
- High level experience and proficiency with Microsoft Excel and data maintenance
- Good written, verbal, and interpersonal skills to effectively interact with cross-functional teams.
- Ability to manage multiple priorities and tasks in a dynamic environment
- Ability to work in a team environment or independently with minimum supervision on day-to-day activities
- Experience with material specification and testing with preference in GMP environment.
- Experience with FDA/GMP regulations with preference of USP, EP and ICH Guidelines.
- Experience with compendial reviews for new and/or revised compendial requirements.
- Experience in preparation of raw material specification documents and certificate of analysis.
- Very high level of Microsoft Excel proficiency
- Experience with SAP system.
- 1 to 3 years working in GMP environment.