Scientist 1 - Custom Validation Virology

Merck•Rockville, MD

About The Position

The Scientist 1 – Custom Validation Virology role supports assay development through the commercial application of new and innovative service offerings in biosafety testing. The Scientist is responsible for the scientific integrity of technical laboratory work, making scientific observations, maintaining detailed workbooks and documentation, and ensuring documentation meets generally accepted professional and industry standards. The role performs testing in accordance with SOPs and cGMP/GLP regulations, applies laboratory techniques to experiments addressing specific problems, and independently applies basic scientific principles to experiment design and assay development. For GLP studies, the Scientist acts as Study Director and maintains complete records to support study integrity. The position also includes equipment operation and maintenance, data analysis, troubleshooting, technical reporting, SOP and laboratory-record updates, staff training, and contribution to continuous improvement. The Scientist communicates study progress and issues, leads event-record completion, and works with Quality Assurance and cross-functional departments to close events and corrective actions. The role may act as a subject matter expert and project-team champion.

Requirements

Ph.D. in a scientific field and at least 1 year of laboratory-setting work experience; or a Master's degree in a scientific field and at least 2 years of laboratory-setting work experience; or a Bachelor's degree in a scientific field and at least 5 years of laboratory-setting work experience; or a high school diploma or GED and at least 9 years of laboratory-setting experience.
Eligible to work in the United States; the role does not offer work-authorization sponsorship.

Nice To Haves

Laboratory experience executing and overseeing technical projects or related studies in virology, specifically using qPCR, cell culture techniques, and viral agents.
Previous experience working in a GMP/GLP environment.
High technical competence and recognition as a scientific leader in a particular scientific area.
Excellent oral and written communication skills, including experience with presentations or seminars, project oversight, and implementation of new services.
Excellent time-management skills.
Ability to work collaboratively as well as independently.
High level of initiative.
Intermediate proficiency in Microsoft Office products, including Word, Excel, PowerPoint, and Outlook.

Responsibilities

Support assay development and commercial application of new service offerings in biosafety testing.
Ensure the scientific integrity of technical laboratory work and maintain detailed, complete, and compliant documentation.
Perform testing in accordance with SOPs and cGMP and GLP regulations.
Act as a subject matter expert for defined areas of the BioReliance business.
Apply laboratory techniques and skills to experiments designed to address specific problems.
Independently apply basic scientific principles to experiment design and assay development.
Act as Study Director for GLP studies and maintain comprehensive records supporting study integrity.
Make detailed observations, document results, and perform data analysis.
Operate and maintain laboratory equipment according to SOPs and testing procedures.
Use applicable computer programs for testing and routine tasks, including Word, Excel, Oracle, LIMS, and BRIQS.
Use problem-solving and troubleshooting skills.
Communicate deviations, events, progress, and interim results to Study Management.
Lead completion of event records and liaise with Quality Assurance and cross-functional departments to close events and corrective actions identified during GxP laboratory testing.
Maintain working knowledge of laboratory procedures and assays.
Create or revise SOPs, laboratory records, and related documentation as assigned.
Write technical reports for internal use and collaborate on papers for external use.
Train laboratory personnel as needed or assigned.
Suggest improvements to laboratory techniques, protocols, processes, and equipment.
Act as a key driver or champion on project teams.
Comply with company health and safety regulations and procedures.