The ADC Laboratory Analyst is responsible for the execution and documentation appropriately of testing and analysis of Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Quality Standards and/or other approved protocols. To provide analytical support to product quality investigations including the use of sophisticated analytical techniques. To undertake significant assignments and to work on own initiative and with minimum supervision e.g. technology transfer for new product demonstrations; new methods development; management of an on-going programme such as the Intermediate Stability programme & to provide training for other Laboratory Analysts and other lab personnel.
• The Laboratory Analyst has responsibility for Raw Material, Intermediate and Drug Substance testing to meet compliance requirements and customer targets. The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level.
• The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP. The Laboratory Analyst assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as HR policies are also responsibilities of the role.
• To test Raw Materials, Intermediates, Drug Substance, Drug products in accordance with Quality Standard and/or other approved protocols.
• To comply with all GMP and analytical procedures relevant to area of work.
• To adhere and comply with department High Performance Analytical Behaviours.
• To document all testing activities and to input results into computerised lab systems in accordance with department and company standards.
• To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
• Complete the investigation of laboratory OOSs in line with site and divisional procedures.
• Complete documentation checks (e.g. PCR’s, ACRs, Deviations) as required for the Drug Substance/Drug Product test package prior to release.
• To complete testing as required on samples to support process changes.
• Accountable for own laboratory safety practices.
• To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
• Provide leadership in the laboratory aspects of OOS investigations.
• To identify and aid resolution of analytical issues within the IPT laboratory.
• To be a resource for analytical testing for the site as required.
• Execute specific assignments (e.g. stability programme, instrument management and other systems) in a comprehensive manner and under minimum supervision.
• Graduate of a science-based discipline.
• Minimum of BSc in Chemistry or related discipline.
• 3-5 years’ experience in a similar position.
• HPLC/GC and Ion Chromotography experience in addition to wet chemistry techniques.
• Empower experience is an advantage.
• Have knowledge of GMP standards.
• Have knowledge Laboratory safety standards.
• Must have good communication skills, both written and verbal.
• Strong documentation skills are required.
• Must be motivated, focused and technically strong.
• To perform analytical testing with a high degree of precision and accuracy.
• To perform instrument maintenance and troubleshooting.
• To maintain accurate records in compliance with GMP expectations.
• To understand and internalise procedures relevant to GMP operations.
• To communicate clearly and concisely on technical issues.
• On assignment, to deliver project goals on time.
• Analytical chemistry – demonstrated ability in all technical elements relevant to Ballydine ADC IPT operation.
• Technical lab skills (precision, etc.)
• Strong aptitude for handling analytical instruments.
• Mechanical and computer.
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