MSD AR&D Bioassay Scientist 

Ireland 

623342818

Job Description

The Biologics Analytical Research & Development department is seeking applicants for an Associate 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 methodvalidations/transfers.

The Scientist will run daily activities in the Bioassay/PCR laboratories.

Main areas of responsibility include:

• Execution of analytical method validations and transfers (among different sites, and between our company and CROs) and write technical protocols and report
• Execution and review of analytical testing of drug substance release, stability, incoming raw materials, ID testing and characterization for biologics under GMP/GDP
• Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers.
• Support equipment maintenance, calibration and qualification work
• Preparation, review & authoring of SOPs and other documents as required
• Author & Review of Analytical methods
• Ability to organise and establish testing schedules and adhere to deadlines.
• Perform periodic reviews of instrument systems.
• Initiate, review, and approve deviations, CAPAs, and, risk assessments, and change records as required.
• Generate instrument data in support of SDLC Validation.
• Other analytical activities in consultation with the Associate Director or designee
• Works in accordance with applicable internal company regulations: safety, health and environmental protection.

Required Education:

• BSc in AnalyticalChemistry/Biochemistryor related field or BA.

Required Experience and Skills:

• Experience with biochemical analytical techniques and antibody biochemistry, binding assays, functional cell-based assays, PCR.
• Strong oral and written communication skills
• Ability to work in a team environment with cross-functional interactions is essential.
• GMP working experience
• Cross-train Scientists within the department for new and existing technologies.

Preferred experience and skills:

• Understanding of current manufacturing processes
• Analyse and optimise current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies.

So, if you are ready to:

Current Contingent Workers apply

Not Applicable

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