Key responsibilities include:
· Carry out analytical testing in a timely manner for analytical method development, analytical testing, validation and qualification, where appropriate to ensure project deadlines are achieved for:
o Campaign support,
o Material release,
o R&D Chemistry lab work (use-tests, familiarisation experiments),
o Material Stability program,
o Reference standard qualification,
o Analytical investigations.
· Prepare, review and execute analytical protocols.
· Prepare and review analytical reports.
· Ensure all documentation is completed to the required standard, right first time, in compliance with local procedures and in a timely manner.
· Ensure all instrumentation used is within calibration and is correctly maintained.
· Liaise with AR&D Senior Analytical Chemists to obtain technical support with instrumentation/analytical methodology and laboratory investigations/quality events or related issues.
· Ensure training is completed before execution of a task.
· Attend weekly team meetings and participate in a culture, which is committed to high performance,
innovation, and continuous improvement and promotes idea sharing.
· Meet with manager to discuss performance, provide feedback and identify any development opportunities.
· Ensure GMP Compliance of laboratory operations and documentation, including testing, write ups, review and approval of protocols, reports and change controls.
· Ensure a safe work environment for oneself and all employees.
· Ensure high standards of housekeeping are maintained in the laboratory.
Required Key Skills and Experience include:
· Ideally a BSC/MSc in analytical chemistry or equivalent. Preferably a minimum of 2 to 4 years’ experience in analytical activities/QC environment within a pharmaceutical manufacturing environment.
· Excellent core competencies such as teamwork, communication skills, technical writing skills.
· Strong technical background in chemistry, particularly analytical chemistry.
· Ability to work to tight timelines.
· Good Troubleshooting skills.
· Openness to change, receptive to new ideas.
· Knowledge of FDA and European GMPs requirements, particularly pertaining to laboratory operations.