Summary: The Principal Scientist - Analytical will be a key contributor within the Technical Operations Science and Innovation (TOSI) organization, providing technical support and expertise in analytical methods for drug product improvement and regulatory submissions. This role involves leadership in resolving analytical method issues, supporting product transfers, and ensuring compliance across sites. The position requires collaboration with various technical functions to enhance scientific capabilities and operational efficiency. The ideal candidate will possess significant experience in regulatory submissions and analytical method optimization within the pharmaceutical industry.

Key Responsibilities:

• Serve as the responsible expert for major commercial products related to Analytical subject matter areas.
• Lead and support regulatory file authoring, review, and responses to regulatory questions.
• Provide technical expertise to resolve analytical method issues impacting supply.
• Develop corrective and preventive actions in support of investigations.
• Support the transfer of established product analytical methods to external manufacturing partners.
• Lead complex technical improvements and change activities to assure product performance.
• Oversee analytical method lifecycle activities for compliance across sites.
• Identify opportunities for analytical method improvements and provide training in expertise areas.

Key Skills:

• Significant experience in preparing regulatory submissions and responses.
• Excellent understanding of Oral Solid Dosage (OSD) product life-cycle management.
• Knowledge of analytical methods establishment, optimization, and control of drug products.
• Experience in analytical methods optimization and transfer.
• Strong issue investigation and change assessment skills from an analytical perspective.
• Familiarity with root cause analysis tools.
• Thorough understanding of SHE/EHS or HSE and cGMP principles.
• Excellent communication skills and relationship-building abilities.
• Strong leadership skills with experience in cross-functional collaboration.
• Experience in Lean and problem-solving tools, along with data analysis skills.
• Master's Degree with 5 years of experience or PhD with 3 years of experience in pharmaceuticals is preferred.
• Pharmacopeial experience is a plus.

Salary (Rate): undetermined

City: undetermined

Country: United Kingdom

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other