Process Development Analyst

Cpl in partnership with our client Pfizer are seeking a process development Analyst to join the team for a 12 month fixed term contingent contract at their Ringaskiddy Site. This is an onsite working Role. 

Role Summary

·       Development and implementation of analytics for new API processes and technology in manufacturing sites.

·       Provide technical support and leadership for supply assurance projects.

Role Responsibilities

• Apply highly specialised analytical skills to support chemical process development, pilot plant demonstrations and full-scale qualification batches as part of the Development team.
• Develop, evaluate & verify analytical methods across a range of techniques as required to support projects.
• Provide analytical testing across a range of techniques to support chemical process development, pilot plant demonstrations and full-scale qualification batches as part of the team.
• Contribute a range of highly innovative analytical ideas to support global process development projects.
• Demonstrate problem solving delivering process and analytical understanding.
• Provide analytical support in technical transfer of analytical methods to manufacturing sites.
• Co-ordinate and/or contribute to analytical validation and method transfer (MT) activities as required by project demands.
• Contribute and/or lead troubleshooting and investigation of analytical issues with existing commercial API processes to support project teams, API sites (internal and external) and global technical groups.
• Investigate new technologies and analytical approaches.
• Complete reports, memos and lab notebooks experiments to a high standard and meeting required deadlines.
• Contribute to the analytical team program of continuous improvement.

·       Ensure the ongoing safe and efficient operation of facilities.

Role Requirments

·       Extensive knowledge and experience of analytical principles and procedures.

·       Practical experience in a range of analytical techniques including but not limited to HPLC, UPLC, GC, SFC, LC-MS/MS, GC-MS, KF.

·       A strong background in impurity isolation and identification using LC-MS to support the development and troubleshooting of chemical processes is desirable.

·       Experience in HPLC/UPLC method development. GC method development experience is desirable.

·       Experience in pGTI method development and quantification is desirable.

·       Experience of method validation and method transfers, including the generation and review of MT and validation protocols and reports is desirable.

·       A proven ability to plan and work independently. The candidate must be able to work under consultative direction, toward predetermined long-range goals and objectives for a project. Project management experience a plus here.

·       The candidate should have the ability to determine and pursue courses of action necessary to obtain desired results. Develops advanced ideas and guides their development into a final product.

·       Demonstrated application of 6-sigma tools and practices and a focus on continuous improvement for work processes.

·       Excellent interpersonal skills and the ability to work in a collaborative, team driven environment.

·       Excellent written and verbal communication skills.

·       A PhD in analytical chemistry ideally combined with 0+ years’ experience in the pharmaceutical industry, ideally within an analytical development role; or a BSc/MSc in a degree with significant analytical focus and ideally up to 2+ years’ experience in the pharmaceutical industry, ideally within an analytical development role. Experience in project management, complex analytical investigation and method development is desired for this role.