Analytical Chemist

Website TPM05409

Summary:
Our client, a biopharmaceutical company located in South Tipperary, is seeking an Analytical Chemist. The ideal candidate will be responsible for the execution and appropriately document testing of Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols. The successful candidate will provide analytical support to product quality investigations including the use of sophisticated analytical techniques, undertake significant assignments and to work on own initiative and with minimum supervision, e.g. technology transfer for new product demonstrations, new methods development; management of an on-going programme such as the Intermediate Stability programme, and to provide training for other chemists and other lab staff.

Responsibilities:

  • May take a leadership role in change or improvement projects in ADC or at a site level.
  • Responsible for ensuring all testing activities comply with cGMP.
  • Assure compliance with all safety and environmental requirements.
  • Compliance with other regulated areas such as HR policies are also responsibilities of the role.
  • Test Raw Materials, Intermediates, Drug Substance & Drug Product in accordance with Analytical Standards and/or other approved protocols.
  • Comply with all GMP and analytical procedures relevant to area of work.
  • Adhere and comply with department High Performance Analytical Behaviours.
  • Document all testing activities and to input results into computerised lab systems in accordance with department and manufacturing standards.
  • Provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
  • Complete the investigation of laboratory OOSs (Z1 Quality Notifications), in line with site and divisional procedures, and Provide leadership in the laboratory aspects of OOS investigations.
  • Complete documentation checks (e.g. GCM’s, Quality Notifications, Data Integrity) as required for test packages prior to release.
  • Complete testing as required on non-routine samples to support process changes, Request for Service, Quality Notifications.
  • Accountable for own laboratory safety practices. Follow the principles of Safe by Choice.
  • Provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
  • Identify and aid resolution of analytical issues within the operations laboratory.
  • Be a resource for analytical testing for the site as required.
  • Execute specific assignments (e.g. DI Initiatives, Lab X Champion, Empower/LIMS Superuser and other systems) in a comprehensive manner and under minimum supervision.
  • Complete training with new laboratory Analysts and Laboratory Apprentices.
  • On assignment, and depending on experience, participates in or leads departmental initiatives on improved compliance and quality systems.
  • Operates as part of self-directed team in allocating testing and assigning priorities.

Qualifications & Experience:

  • B.Sc. in Chemistry or related discipline.
  • Demonstrated knowledge of manufacturing and site quality policies, procedures and guidelines which relate to finished product testing and release.
  • Knowledge of relevant GMP and Lab safety standards.
  • Experience in performing analytical testing with a high degree of precision and accuracy.
  • Experience in instrument maintenance and troubleshooting.
  • Act as auditee (in internal and external audits) for assigned areas of responsibility.

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