Senior Analytical Chemist

Senior Analytical Chemist

SK pharmteco are seeking to recruit an experienced Senior Analytical Chemist/Team Lead on a permanent basis based at Swords, County Dublin.

Position Description:

The Senior Analytical Chemist/Team Lead is responsible for providing technical expertise to ensure successful development and validation of phase appropriate analytical methods pertaining to the manufacture of small molecule APIs and intermediates. The successful candidate will also act as the technical analytical team lead for new product introduction (NPI) projects and 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 give direct supervision and provide technical leadership to the analytical chemists.

Key responsibilities include:

·      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.

Required Key Skills and Experience include:

·      Ideally a 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.

Other Benefits include:

·      Excellent opportunities for career enhancement and personal development.

·      Competitive base salary.

·      Annual bonus linked to business results.

·      A well-established further education program.

·      Pension scheme.

·      Private Healthcare Insurance.