Senior Scientist I, Analytical Operations Outsourcing

Senior Scientist I, Analytical Operations Outsourcing

Job Description

Responsibilities

• Manage outsourcing activities as the single point of contact for the 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.
• Accompany outsourced analytical work packages from initial request over quote, contract, testing order, analyses related coordination to invoice verification to meet given timelines and budget.
• Support monitoring of service providers and the identification and qualification of new external partners.
• Author, verify and archive documents in a GMP environment
• Work with different areas towards a standardized, compliant, and effective global outsourcing process.
• Support with the management of investigations occurring at external and internal service providers
• Act as a change owner following the applicable CM process
• Provide the necessary QCC support for outsourced analytical work
• Develop/align local processes/workflows and GMP approaches within PDS&T LC and global processes in close cooperation with other PDS&T sites and partner organizations.

Qualifications

• Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD and no experience necessary.
• Possess thorough theoretical and practical understanding of own scientific discipline.
• Minimum 3 years of experience in the pharmaceutical industry with exposure to analytical and/or formulation development and expertise in GMP areas.
• Knowledge of GMP requirements and regulations.
• Is self-motivated, self-reliant, hard-working, and able to work in a fast-paced global environment
• Learns fast, grasps the essence and can change course quickly when indicated to manage and meet priorities and timelines
• Pays attention to quality and detail
• Brings good communication and collaboration skills
• Demonstrated problem solving skills
• Is competent with software programs, including MS Excel, PowerPoint, Word, Power BI
• Has proven flexibility to deal with changing timelines and shifting work priorities.