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 contract at their Cork site.
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Job Summary:
* Develop and implement analytics for new API processes and technology in manufacturing sites.
* Provide technical support and leadership for supply assurance projects.
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Key Responsibilities:
1. Apply highly specialized analytical skills to support chemical process development, pilot plant demonstrations, and full-scale qualification batches as part of the Development team.
2. Develop, evaluate, and 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 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. Coordinate and/or contribute to analytical validation and method transfer (MT) activities as required by project demands.
8. Contribute to 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 to a high standard and meeting required deadlines.
11. Contribute to the analytical team's program of continuous improvement.
12. Ensure the ongoing safe and efficient operation of facilities.
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Requirements:
* Extensive knowledge and experience of analytical principles and procedures.
* Practical experience in a range of analytical techniques including HPLC, UPLC, GC, SFC, LC-MS/MS, GC-MS, KF.
* A strong background in impurity isolation and identification using LC-MS is desirable.
* Experience in HPLC/UPLC method development, GC method development, and pGTI method development and quantification is desirable.
* Experience in method validation and method transfers is desirable.
* A proven ability to plan and work independently and manage projects effectively.
* The ability to determine and pursue courses of action necessary to obtain desired results.
* 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 environment.
* Excellent written and verbal communication skills.
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$80,000 - $100,000 per annum