Manager, Senior Scientist, Quality Control Laboratory

The Senior Scientist will serve as the designated point of contact for Aichi and the analytical network, frequently interacting with global analytical science and product development teams. The incumbent will be subject matter expert for the analytical portion of new product introduction and for a number of test methods/processes across multiple products, anticipate and perform complex troubleshooting and problem-solving independently.

Requirements

• Designated subject matter expert for a number of test methods/processes across multiple products
• Leads method transfer & validation of in-process, final product, and stability methods specifically focusing on new product introduction
• May own scheduling of assignments in consultation with manager
• Independently develop, write, and execute methods, protocols, reports, and other related documents aligned with regulatory and corporate guidelines
• Represent the department in product review boards and regulatory inspections (internal and external audits)
• May author responses to regulatory requests
• Lead projects, CAPAs and deviations/ investigations and/ or continuous improvement efforts
• Anticipate and perform complex troubleshooting and problem solving independently
• Train and mentor others on multiple QC test methods, processes and procedures
• Perform other tasks as assigned
• Owns and contributes to change controls
• May act as delegate for laboratory management, as required
• Perform release/stability testing for complex and non-complex methods on intermediate or finished product as required
• Identifies and escalates challenges & barriers to execution, suggests solutions, and lead remediation
• Champion and foster a positive, supportive, and collaborative quality culture
• Actively and positively participates or leads in Operational Excellence (OpEx) and Continuous Improvement (CI) initiatives in the team
• Complete all required tasks compliantly and safely while consistently and intentionally modeling BMS values (Integrity, Accountability, Passion, Urgency, Innovation, and Inclusion)

Benefits

• Competitive benefits
• Services
• Programs