AR&D Analytical Chemist

Cpl in partnership with SK biotek are seeking to recruit an experienced AR&D Analytical Chemist to join R&D Centre in Swords, Co Dublin for a 12 month contract.

The R&D Centre has co-located technical and operational expertise, including analytical expertise that supports the development and manufacture of clinical and commercial products (small molecule APIs).

The Analytical Chemist will be 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 also provide support in the day-to-day running and maintenance of the AR&D laboratories, including equipment. The successful candidate will collaborate closely with other functions, including R&D Chemistry, Operations, Quality (QA/QC), SHE and external stakeholders/customers working towards the flawless, compliant and right first time manufacture of existing and new products. In addition, the successful candidate will provide mentorship, where applicable, to more junior analytical staff.

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:

-           Campaign support,

-           Material release,

-           R&D Chemistry lab work (use-tests, familiarisation experiments),

-           Material Stability program,

-           Reference standard qualification,

-           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 4 years’ experience in analytical activities 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.