Key Responsibilities:
This role is responsible for providing technical support for all aspects of analytical methodology, development, transfer, qualification and troubleshooting pertaining to the manufacture of small molecule APIs and intermediates.
The successful candidate will be responsible for carrying out analytical testing in a timely manner for analytical method development, analytical testing, validation and qualification, where appropriate to ensure project deadlines are achieved.
Responsibilities include preparing, reviewing and executing analytical protocols, preparing and reviewing analytical reports, ensuring all documentation is completed to the required standard, right first time, in compliance with local procedures and in a timely manner.
The Analytical Chemist will also ensure that all instrumentation used is within calibration and is correctly maintained, liaise with 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.
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:
A BSc/MSc in Analytical Chemistry or equivalent and preferably a minimum of 4 years' experience in analytical activities within a pharmaceutical manufacturing environment.
Excellent core competencies such as teamwork, communication skills, technical writing skills and strong technical background in chemistry, particularly analytical chemistry.
Ability to work to tight timelines, good Troubleshooting skills and openness to change, receptive to new ideas.
Knowledge of FDA and European GMPs requirements, particularly pertaining to laboratory operations.
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