Data Scientist (Expert) - Data Science - R&D - PH ...

Formulation Development (FD) department within Bayer Consumer Health R&D located in Morristown, NJ, is committed to developing best in class OTC products. FD develops pharmaceutical drug products in their final dosage forms such as tablets, softgels, liquids etc. Operationally, FD works very closely with departments such as Analytical Development, Tech Transfer, Clinical Supplies, Packaging, Regulatory, Medical & Marketing. Bayer FD has developed iconic brands trusted by millions of consumers such as Alka-Seltzer, Claritin, Aleve, One-A-Day Vitamins, MiraLAX, Afrin etc.

POSITION SUMMARY / REQUIREMENTS

• The Scope for the PDV Scientist is help design, review and test the future state Product Life Cycle Management (PLM) database system and include all global / local variations as well as project types (NPD, NPIs, MCMPs, etc.).
• The PDV scientist will liaison primarily between Formulation Development within the R&D and collaborate with external divisions such as Product Supply, Procurement, and Information Technology in designing a comprehensive database.
• The ideal candidate will have a proven track record in managing systems technology and business processes.
• He/she should have significant experience in cross-functional initiatives with a detailed knowledge of the end-to-end Formulation process, Product Lifecycle Management systems, Supply Chain systems, overall database functionality and understanding of Change Management processes within the pharmaceutical industry.
• He/she should monitor, analyze, troubleshoot and rectify any quality or completeness issue with system data and processes.
• The PDV scientist must develop, run and analyze system reports to ensure data accuracy. He/she should also know to configure, implement, and maintain system workflows, user profiles, routine lists and processes for the CH Formulation Product Lifecycle Management (PLM) as directed.

POSITION DUTIES & RESPONSIBILITIES

• Serve primarily Formulation Development (FD) Department and work with other departments such as Medical, Regulatory etc., within R&D. In addition, collaborate with Departments outside of R&D such as Product Supply, Procurement, etc.
• Raw Material Management related to FD (especially introducing new raw materials) , Experimental Formula Development, Prototype Development, Physical Product Testing, Analytical Testing, Regulatory Compliance, Medical, Tox and Human Safety Reviews
• Supplier Management related to FD (includes contract labs and any external vendors involved during the formula development process), Product Changes (especially re-formulation changes which are not managed by business protection), Specification in PLM (entering the locked specifications in PLM), Innovation Management (not specific to an NPD project),
• Product change management and dual maintenance of PLM with SYNAPS (with Packaging data residing in SYNAPS and Formulation Data in new PLM we need a robust product change management process to ensure correct data flow to the Finished Good and Bulk in SAP ECC
• Impact Analysis related to FD, API Changes, Non-API changes, lifecycle status and workflow of change, change objects (change order, change notice, change action, etc.), executing changes in SAP ECC, material master updates, NPD vs NPI, change implementation with CMOs / co-packers
• Full oversight and ownership of data accuracy and integrity through management of systems and information, enabling effective formulation change control process and business continuity.
• Material master management, data stewardship and governance, mandatory attributes in PLM and ERP, Global master data vs local master data, approval and change management process to update master data (supplier data, raw materials, etc.), end-of-life management and discontinuation of specific master data objects
• Define project stage gates, standardize various project types and workflows associated (USPJR, NPD, NPI etc.), entry and exit criteria for each stage gate, document management, dashboard and reporting
• Manage product changes, change execution, coordinate with R&D for major re-formulation changes, coordinate with regulatory on impact to dossier and registration for major changes
• Ensure continuity of the PLM system through the Formulation Change Control, and approval process
• Maintain system validation and training documents in accordance with GMP, CFR-Part 11 and change control requirements where needed
• Oversee IT analyst(s) / developers to evaluate current state and implement system changes impacting local CH US systems.
• Responsible for KPI reporting on processes housed within the CH PLM system. Use data to provide proactive changes to ways of working.
• Quality reviews as per SOPs, management of CAPAs and deviations, batch record approvals by site quality

REQUIREMENTS/PREFERENCES

Education Requirement(s):

• Bachelor of Science in Information Technology and/or Pharmaceutical Sciences or related with at least 6 years of experience in designing infrastructure network systems with experience in Formulation and/or Manufacturing and/or Processing Development, ideally in a GMP environment

Required Skills:

• Development of network systems for creating pharmaceutical databases
• Knowledge of pharmaceutical product development workflow typically followed in any pharmaceutical company formulating and manufacturing human drug products

Preferences:

• Information Technology/Pharmaceutical Industry and/or academic experience working on product development with significant expertise in collaborating with various functions within R&D
• Demonstrated ability to design workflow systems, identify and apply the scientific aspects and communicate with all levels of personnel the results of projects.
• Ability to manage raw material specifications, regulatory agency inquiries/documentation related to product technical issues.
• Ability to work in a team-oriented environment and work independently in a changing environment.

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