Job Description
Our site in Dunboyne will be a premier, state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch.
Our site in Dunboyne serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong to our site in Dunboyne, but that the facility belongs to and is shaped by them.
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 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 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 reports
* 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 Analytical Chemistry/Biochemistry or 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:
Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.
Current Employees apply HERE
Current Contingent Workers apply HERE
#J-18808-Ljbffr