Molecule Steward

Responsibilities

The mission of Technical Services/Manufacturing Sciences (TS/MS) is to provide scientific leadership and technical support for manufacturing to make medicine. The Site Molecule Steward is the subject matter expert for the Concord Site Drug Product manufacturing and will provide local technical leadership and expertise for projects involving TS/MS. Key Objectives/Deliverables

• Assume ownership of control strategy implementation and execution at the manufacturing site.
• Interact with peers across the parenteral network, including TS/MS, QA, QC, Regulatory and Engineering, both site and central.
• Share learning and ensure strategies are in line with technical, quality, and regulatory guidance, while supporting business expectations.
• Play a critical role in technical capability building and coaching at the site to ensure capabilities are in place to meet business objectives.
• Serve as technical subject matter expert for all topics related to drug product manufacturing.
• Expected to provide technical direction on deviations, production challenges, and impact assessment of change controls.
• Serve as a representative for the TS/MS function in regulatory interactions, as needed.
• Be responsible and influential with respect to implementation of external/corporate trends and understanding of how these changes could impact the Concord site.

Qualifications

• Minimum of bachelor's degree in science or engineering field.
• Minimum of 5 years directly supporting parenteral product manufacturing.

Additional Skills/Preferences

• Strong communication skills.
• Capability to prioritize and multi-task effectively.
• Collaborate with other functions as teams as appropriate.