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 Cork, Ringaskiddy/Shanbally site.
Role Summary:
1. Development and implementation of analytics for new API processes and technology in manufacturing sites.
2. Provide technical support and leadership for supply assurance projects.
Job Responsibilities:
1. Apply highly specialised analytical skills to support chemical process development, pilot plant demonstrations and full-scale qualification batches as part of the Development team.
2. Develop, evaluate & verify analytical methods across a range of techniques as required to support projects.
3. 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.
4. Contribute a range of highly innovative analytical ideas to support global process development projects.
5. Demonstrate problem solving delivering process and analytical understanding.
6. Provide analytical support in technical transfer of analytical methods to manufacturing sites.
7. Co-ordinate and/or contribute to analytical validation and method transfer (MT) activities as required by project demands.
8. 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.
9. Investigate new technologies and analytical approaches.
10. Complete reports, memos and lab notebooks experiments to a high standard and meeting required deadlines.
11. Contribute to the analytical team program of continuous improvement.
12. Ensure the ongoing safe and efficient operation of facilities.
Qualifications/Skills:
1. Extensive knowledge and experience of analytical principles and procedures.
2. Practical experience in a range of analytical techniques including but not limited to HPLC, UPLC, GC, SFC, LC-MS/MS, GC-MS, KF.
3. A strong background in impurity isolation and identification using LC-MS to support the development and troubleshooting of chemical processes is desirable.
4. Experience in HPLC/UPLC method development. GC method development experience is desirable.
5. Experience in pGTI method development and quantification is desirable.
6. Experience of method validation and method transfers, including the generation and review of MT and validation protocols and reports is desirable.
7. 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 is a plus here.
8. 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.
9. Demonstrated application of 6-sigma tools and practices and a focus on continuous improvement for work processes.
10. Excellent interpersonal skills and the ability to work in a collaborative, team driven environment.
11. Excellent written and verbal communication skills.
Specific Requirements for each Global Job Level:
1. For Research Analyst (GJL060), 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.
Skills:
HPLC, UPLC, GC, SFC, GC-MS, KF, method validation
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