Sr. Principal Scientist - Molecule Steward
- Assume ownership of control strategy implementation and execution at the manufacturing site.
- Lead the technical transfer for applicable products to the 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.
- Generate documentation to support the product/program, as needed.
- Represent 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.
- Excellent technical writing and oral communication skills along with the ability to effectively communicate and transfer knowledge to all levels of the organization.
- Although not a supervisory role, technical leadership, and the ability to cross functionally influence are important in this role.
- Minimum of bachelor's degree in science or engineering field,
- Minimum of 5 years directly supporting parenteral product manufacturing.
- Strong communication skills
- Capability to prioritize and multi-task effectively.
- Collaborate with other functions as teams as appropriate.
- This position is tech ladder approved (R4+). Position final level will be based upon the level of the candidate chosen.
- This position will be required to collaborate with peers across the network.
- This position is day shift, Monday-Friday, with off hours support needed, by request.
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