Website Ref: TPM04385
A biopharmaceutical company in Dunboyne requires a Scientist to join their Biologics Analytical Research & Development department. The position is a laboratory-based scientific role tasked with analytical testing of drug substance for release, stability and characterization of biologic products under GMP/GDP, perform analytical method qualification via analytical method transfers, analytical method validation. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. The Analytical Scientist will run the daily activities in the Analytical laboratories
- Participate in the start-up of operations within the new laboratory facility which will include support of equipment qualification, documentation generation such as SOP’s, Work instructions authoring and review as well as contributing to lab and process work flow establishment.
- Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers.
- Ability to organise and establish testing schedules and adhere to deadlines.
- Execution of analytical method validations and transfers (among different sites, and between the company and CROs) and write technical protocols and report.
- Execution of analytical testing of drug substance release, stability and characterization for biologics under GMP/GDP.
- Support equipment maintenance, calibration and qualification work.
- Preparation of analytical methods, SOPs and other documents as required.
- Other analytical activities in consultation with the Supervisor.
- Works in accordance with applicable internal company regulations: safety, health and environmental protection.
Qualifications & Experience:
- B. Sc. in analytical chemistry/biochemistry or related field or BA. An advance degree (MSc) qualification is desirable.
- 2-4 years of experience in the Pharmaceutical Industry,
Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique.
- Experience with biochemical analytical techniques and antibody biochemistry, binding assays as ELISAs and functional cell-based assays.
- Analytical Instrumentation Qualification.
- Strong oral and written communication skills.
- Ability to work in a team environment with cross-functional interactions is essential.
- GMP working experience.
- Experience on analytical method qualification and transfers.
To apply for this job email your details to email@example.com.