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 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 between our organization and CROs) and write technical protocols and report
- Execution of analytical testing of drug substance release, stability and characterization for biologics under GMP/GDP
- Troubleshoot methods to ensure seamless method qualification & execution in the laboratory
- Support equipment maintenance, calibration and qualification & periodic review
- Preparation of analytical methods, SOPs and other documents as required
- Other analytical activities in consultation with the Associate Director or designee
- Works in accordance with applicable internal company regulations: safety, health and environmental protection.
- Cross-train Scientists within the department for new and existing technologies.
- Initiate, review, and support deviations, CAPAs, and, risk assessments, and change records as required
- Execution and review of analytical testing of drug substance release, stability, method qualification, incoming goods, ID testing, and characterization for biologics under GMP/GDP.
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
- Demonstrate Problem solving & technical troubleshooting skillset
- Ability to work in a team environment with cross-functional interactions is essential
- GMP working experience
- Ability to organise and establish testing schedules and adhere to deadlines.
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
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
10/23/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R316366