Senior Scientist I, Analytical Operations Outsourcing

Responsibilities:
- Manage outsourcing activities as the single point of contact for internal project teams, QA, business operations, procurement, and the external service provider.
- Coordinate, plan, and monitor outsourced analytical work to external and internal service providers.
- Manage outsourced analytical work packages from request/quote/contract and testing order through analysis coordination to invoice verification, meeting timelines and budget.
- Support monitoring of service providers and identification/qualification of new external partners.
- Author, verify, and archive documents in a GMP environment.
- Work toward a standardized, compliant, and effective global outsourcing process.
- Support investigations at external and internal service providers.
- Act as change owner following the applicable CM process.
- Provide necessary QCC support for outsourced analytical work.
- Develop/align local processes/workflows and GMP approaches within PDS&T LC and global processes in cooperation with other PDS&T sites and partner organizations.

Qualifications:
- Bachelor’s (typically 10 years) or Master’s (typically 8 years) or PhD (no experience required).
- Thorough theoretical and practical understanding of scientific discipline.
- Minimum 3 years pharmaceutical industry experience with exposure to analytical and/or formulation development and GMP expertise.
- Knowledge of GMP requirements and regulations.
- Self-motivated and able to work in a fast-paced global environment.
- Quick learning, ability to adjust course to meet priorities/timelines.
- Detail and quality focused; good communication/collaboration.
- Demonstrated problem-solving skills.
- Competent with MS Excel, PowerPoint, Word, and Power BI.
- Flexibility to handle changing timelines and shifting priorities.

Benefits:
- Paid time off; medical/dental/vision insurance; 401(k) (eligible employees).
- Short-term incentive program eligibility.