Responsibilities:
- Provide scientific leadership and technical support for manufacturing to make medicine.
- Serve as Site Molecule Steward, subject matter expert for Concord Site Drug Product manufacturing, providing 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 (TS/MS, QA, QC, Regulatory, Engineering) site and central.
- Share learnings and ensure strategies align with technical, quality, and regulatory guidance while supporting business expectations.
- Build and coach technical capabilities at the site to meet business objectives.
- Act as technical subject matter expert for drug product manufacturing topics.
- Provide technical direction on deviations, production challenges, and impact assessment of change controls.
- Represent TS/MS in regulatory interactions, as needed.
- Implement and evaluate impact of external/corporate trends on the Concord site.
- Use excellent technical writing and oral communication to convey and transfer knowledge at all organizational levels.
- Provide technical leadership and cross-functional influence (non-supervisory).
Basic Qualifications:
- Bachelor’s degree in science or engineering.
- Minimum 5 years directly supporting parenteral product manufacturing.
Additional Skills/Preferences:
- Strong communication skills.
- Ability to prioritize and multi-task effectively.
- Collaborate with other functions as appropriate.
Additional Information:
- Tech ladder approved (R4+); final level based on candidate.
- Collaboration across the network (Indianapolis, France, RTP) as needed.
- Day shift, Monday–Friday; off-hours support by request.