Analytical Lab Chemist

Website TPM05263

Summary:
Our client, a biopharmaceutical company located in Tipperary, is seeking an Analytical Lab Chemist. The ideal candidate will be responsible for conducting thorough and documented analyses of Raw Materials, Intermediates, Drug Substances, and Drug Products in strict compliance with Analytical Standards and other approved protocols. The successful candidate would also be facilitating technology transfers for new products, developing new methods, overseeing continuous programs such as the Intermediate Stability program, and imparting essential training to fellow chemists and laboratory staff.

Responsibilities:

  • Oversee testing of Raw Materials, Intermediates, Drug Substances, and Drug Products for compliance with regulations and customer requirements.
  • Lead change and improvement projects in ADC or at the site.
  • Ensure testing activities comply with cGMP and safety and environmental regulations.
  • Test Raw Materials, Intermediates, Drug Substances, and Drug Products per Analytical Standards and approved protocols.
  • Document testing activities and input results into computerized lab systems.
  • Provide analytical support for product quality investigations and new product demonstrations.
  • Investigate laboratory Out-of-Specification (OOS) instances.
  • Perform documentation checks for test packages before release.
  • Conduct non-routine sample testing to support process changes and Quality Notifications.
  • Take responsibility for laboratory safety practices.
  • Identify and help resolve analytical issues within the Operations laboratory.
  • Act as a resource for analytical testing for the site.
  • Execute specific assignments comprehensively.
  • Participate in training new laboratory Analysts and Apprentices.
  • Engage in departmental initiatives to improve compliance and quality systems.
  • Collaborate effectively within a self-directed team, prioritizing testing tasks.

Qualifications & Experience:

  • B.Sc. in Chemistry or related discipline.
  • Knowledge of MMD and site quality policies.
  • Familiarity with GMP standards and lab safety.
  • Proficiency in analytical chemistry.

To apply for this job email your details to lara.miranda-pinto@tandempm.ie.