Analytical Scientist (Chemist)

Orion Group Life Sciences are currently recruiting an Analytical Scientist on behalf of our Multinational Biopharmaceutical Client based in Meath on an initial 11-Month contract with potential to extend.

The Biologics Analytical Research & Development department is seeking applicants for a Scientist position which is a laboratory-based scientific role tasked with analytical testing of drug substance for release, stability and characterization of biologic products under GMP/GDP and analytical method validations/transfers. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

The Scientist will run the daily activities in the Biochem laboratories.

Main areas of responsibility include:

• Execution of analytical method validations and transfers (among different sites, 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.
• Train new analysts

Required Education:

• M.S in analytical chemistry/biochemistry or related field or B. S with a minimum of 3 years of experience in the Pharmaceutical Industry.

Required Experience and Skills:

• Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique
• Strong oral and written communication skills
• Ability to work in a team environment with cross-functional interactions is essential

• GMP working experience
• Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers.

• Execution and review of analytical method validations and transfers (among different sites, and between the company and CROs)
• Execution and review of analytical testing of drug substance release, stability, method qualification, incoming goods, ID testing, and characterisation for biologics under GMP/GDP.
• Cross-train Scientists within the department for new and existing technologies.
• Ability to organise and establish testing schedules and adhere to deadlines.
• Support equipment maintenance, calibration and qualification work
• Perform periodic review of instrument systems
• Generate instrument data in support of SDLC Validation.
• Initiate, review, and support deviations, CAPAs, and, risk assessments, and change records as required.
• Preparation of analytical methods, SOPs and other documents as required

Preferred experience and skills:

• Understanding of current manufacturing processes

• Author technical protocols and reports as required
• Analyse and optimise current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.