Analytical Specialist Extractable and Leachables R&D

Major Duties and Responsibilities

Individually contribute or oversee the development, validation and transfer of Extractable and Leachables and Nitrosamines analytical methods.

Ensure developed methodologies are scientifically rugged and review against the requirements of regulatory guidance to ensure dossier submissions are compliant

Individually investigate or lead investigations to successfully resolve analytical problems, project issues and deviations. Accurately maintain all related documentation in compliance with SOPs. Ensure all testing is performed in accordance with testing schedules. Interpret and present analytical results.

Provide support and advice to QC, QA, RA and third parties for product investigations.

Prepare documents for regulatory filings (CTD Module 3), conduct experiments and provide data to support responses to regulatory authorities request for information (RFI)

Participate in cross functional teams at project-related internal and external meetings, lead or facilitate technical discussions.

Maintain interdepartmental relationships and positively promote the department and its objectives.

Remain aware of developments within the scientific fields and ensure all products, processes, and analytical methodologies reflect current best scientific practice.

Successfully investigate and resolve complex analytical problems, project issues and deviations. Accurately maintain all related documentation in compliance with written procedures.

In conjunction with Manager, develop, supervise, and evaluate performance of team members, including This providing technical and procedural training and mentoring for team members and coordinating team member activities to successfully accomplish departmental goals. Including identifying and assessing developmental needs for all team members and addressing with developmental plans. If required, perform periodic and annual review.

Individually contribute to/oversee the development, validation and transfer of analytical methods that will adequately determine the necessary product characteristics that will eventually be required to release drug product and to monitor the storage stability of new products, without supervision.

Perform physical and chemical testing on prototype formulations to determine stability and assign provisional shelf life.

All work performed to comply with GLP and where necessary, GMP including documentation and review.

Work as part of a multifunctional team to compile risk assessments and foresee potential issues and assist in providing solutions to problems.

Undertake such other reasonable duties as may be required from time to time to support the department and business activities.

Acknowledge responsibility to ensure an effective Quality Management System to achieve Quality Objectives.
To produce and/or review validation reports, methods of analysis, COSHH assessments, SOP / WRK instructions, and relevant scientific protocols and other reports in a format that can be utilised by other departments, providing relevant feedback on the content and style of documentation to ensure compliance with company and regulatory requirements
Support the planning and management of analytical activities in support of early new product development (feasibility, prototype, method development, early compatibility studies, raw material evaluation, COSHH assessments). Attend and present data at project-related meetings, interact with internal and external parties to ensure objectives are met.

Competencies

Knowledge and Experience

Typical Years of Experience – 4-8 years’ experience
Minimum Expected Education – Level 6 Bachelor’s Degree
Additional Information – Degree in Lab based science and proven experience in laboratory techniques. Must demonstrate proficiency in Extractables and Leachables and/or Nitrosamine RA and analysis and previous development of analytical methods from first principals and method validation.

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