Senior Analytical Chemist
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We are seeking a highly skilled Senior Analytical Chemist to lead our analytical team in the development and validation of phase-appropriate analytical methods. The ideal candidate will have a strong technical background in chemistry, particularly analytical chemistry.
* Provide technical expertise to ensure successful development and validation of phase appropriate analytical methods.
* Lead analytical technology transfer to site.
* Direct management, supervision and mentorship of analytical chemists.
* Draft and oversee execution of Analytical Qualification Plans (AQPs) and analytical protocols.
* Support R&D analytical chemists in analytical testing for analytical method development, validation, qualification and release testing.
* Carry out analytical testing in a timely manner for analytical method development, analytical testing, validation and qualification, where appropriate to ensure project deadlines are met.
* Ensure GMP Compliance and right first-time completion of all laboratory operations and documentation, including testing, write ups, review and approval of protocols, reports and change controls.
* Review batch paperwork and associated logbooks to ensure testing has been completed in compliance with procedures.
* Provide expert and technical support with instrumentation or analytical methodology and laboratory investigations/quality events or related issues.
* Raise and closeout laboratory investigations/quality events in a timely manner and complete a thorough investigation.
* Champion Empower updates, build and compliance for the group.
* Coordinate and oversee the training of AR&D personnel in new techniques.
* Ensure a culture of OpEx exists within the group and support the OpEx projects.
* Interact with customers and the wider SK network on a project or campaign basis to track progress of activities, identify continuous improvement opportunities and resolve issues.
* Act as technical team lead on a number of projects having responsibility for Analytical milestone delivery on assigned projects.
* Set high performance standards, drive and motivate analytical chemists to achieve individual targets and objectives.
Requirements
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* Ideal BSc/MSc in chemistry or equivalent. Preferably a minimum of 5 years' experience in analytical activities within a pharmaceutical manufacturing environment or a contract manufacturing (CMO) organisation.
* Experience of personnel management or leading teams is required.
* 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 in a high-pressured environment.
* Good Troubleshooting skills.
* Openness to change, receptive to new ideas.
* Knowledge of FDA and European GMP requirements, particularly pertaining to laboratory operations.