- Reference: AJ46535
- Job Type: Permanent
- Location: Galway, Offaly, Westmeath
- Category: Science, Pharmaceutical & Food
The Lead Analytical Chemist will be a key member of the Quality team responsible for analytical stability, raw materials, in-process and finished product testing ensuring efficient and compliant day to day operations.
Analytical Chemist responsibilities:
- Apply technical expertise to method development, execution and troubleshooting of analytical techniques.
- Perform analytical investigations.
- Develop new analytical methods to meet business needs.
- Execute testing and certification/ disposition required for artwork, components, raw materials, finished product and stability testing to meet business goals.
- Prepare CMC analytical sections for MAA applications.
- Lead projects within the Laboratory Services group.
- Provide input to development projects such that they can be executed effectively and in a compliant fashion.
- Transfer/validate in-house methods and verification of compendial methods to ensure overall project schedule timelines are met.
- Lead analytical investigations to establish root cause for atypical, out-of-specification or out-of-trend results.
- Identify and execute on continuous improvement / operational excellence opportunities as they apply to Laboratory Services.
- Laboratory Services signature authority for critical documents.
- Organising the periodic calibration and qualification programme for laboratory equipment.
- Conduct audits of third party contract testing service providers.
- Monitor, evaluate and resolve issues related to day-to-day activities in coordination with Quality and other site functions to assure performance to schedule.
Analytical Chemist requirements:
- BSc/MSc in science discipline required
- 5 years experince in a Pharma/ Biopharma environment.
- Demonstrated technical expertise in multiple analytical techniques (GC, IC, HPLC, dissolution, spectroscopic techniques) and considered an SME in some or all of these techniques.
- Extensive experience in developing new analytical methods for drug product / drug substance analysis.
- Experience with method validation and method transfer and associated troubleshooting required.
- Experience with microbiological testing or working in a sterile manufacturing environment desirable.
For more information or to apply please contact Tina Egan on email@example.com 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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