AR&D Analytical Chemist

SK pharmteco Inc.; Dublin; Hybrid; EUR 55,000 - 75,000; Full time

Job summary

SK pharmteco Inc. at the Swords Campus is seeking an AR&D Analytical Chemist on a 12-month contract to support analytical method development, transfer, qualification and troubleshooting for small molecule APIs and intermediates.

You will collaborate across R&D Chemistry, Operations and QA/QC, maintain laboratory equipment, mentor junior staff and ensure GMP-compliant documentation while delivering timely results.

Qualifications

• BSc/MSc in analytical chemistry or equivalent.
• 3–5 years of analytical experience in a pharmaceutical manufacturing environment.
• Strong teamwork, communication and technical writing skills.
• Knowledge of FDA and European GMPs as they apply to laboratory operations.
• Ability to meet tight timelines and adapt to change.

Responsibilities

• Carry out analytical testing for method development, validation and qualification to meet project deadlines.
• Prepare, review and execute analytical protocols and reports.
• Ensure documentation is completed to required standards, right first time, and compliant.
• Maintain calibration and service of laboratory instrumentation.
• Collaborate with AR&D Senior Analytical Chemists for technical support and investigations.
• Provide training to junior analytical staff where applicable.
• Ensure GMP compliance of laboratory operations and safe working environment.
• Maintain high standards of housekeeping in the laboratory.

Skills

Analytical Chemistry

Teamwork

Communication

Technical Writing

Meeting Timelines

Adaptability

GMP Knowledge

Education

BSc/MSc in Analytical Chemistry or equivalent

Tools

Analytical instrumentation

Job description

Cpl in partnership with SK pharmteco at the Swords Campus are looking for an AR&D Analytical Chemist on a 12-month contract.

Position Description:
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.

Key Requirements for this role include:

• Ideally a BSC/MSc in analytical chemistry or equivalent. Preferably a minimum of 3 to 5 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.
• Openness to change, receptive to new ideas.
• Knowledge of FDA and European GMPs requirements, particularly pertaining to laboratory operations.