Lead Analytical Chemist

Collins Mcnicholas Recruitment

Westmeath

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 tina.egan@collinsmcnicholas.ie 09064 78104. Please Note: Collins McNicholas will not forward your details to any company without your prior approval. Setting the Standards for Excellence in Recruitment. To see a full list of jobs available across Ireland please visit our website atwww.collinsmcnicholas.ie. This job originally appeared on RecruitIreland.com.

2167 days ago