Scientist 1 - Custom Validation Virology

The businesses of Merck KGaA, Darmstadt, Germany•Rockville, MD

2d•$75,100 - $112,600

About The Position

At MilliporeSigma, the Scientist 1 – Custom Validation Virology supports assay development through the commercial application of new and innovative service offerings in biosafety testing. The role is responsible for the scientific integrity of laboratory work, making scientific observations, maintaining detailed workbooks and documentation, and ensuring documentation meets generally accepted professional and industry standards. The Scientist performs testing in accordance with SOPs and cGMP/GLP regulations; serves as a subject matter expert in defined areas of BioReliance business; applies laboratory techniques and basic scientific principles to experiments and assay development; and, for GLP studies, acts as Study Director. The role maintains complete study records, documents and analyzes results, operates and maintains laboratory equipment, uses applicable computer programs, troubleshoots issues, communicates study progress and events, and leads event record completion. The Scientist also works with Quality Assurance and cross-functional teams to close events and corrective actions, maintains knowledge of laboratory procedures and assays, creates or revises documentation, writes technical reports, trains laboratory personnel as assigned, contributes process improvements, and champions project teams. The role follows company health and safety procedures. The position does not offer work authorization sponsorship; external applicants must be eligible to work in the United States. The stated pay range is $75,100–$112,600. The role may offer medical, vision and dental insurance, life and disability insurance, 401(k) matching, paid time off, paid holidays, and possible short- or long-term incentive compensation, including cash bonuses.

Requirements

Ph.D. in a scientific field and at least 1 year of laboratory work experience, or a master's degree in a scientific field and at least 2 years of laboratory work experience, or a bachelor's degree in a scientific field and at least 5 years of laboratory work experience, or a high school diploma/GED and at least 9 years of laboratory experience.
External applicants must be eligible to work in the United States; work authorization sponsorship is not offered.

Nice To Haves

Knowledge and laboratory experience executing and overseeing technical projects or related studies in virology, particularly 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.
Strong oral and written communication skills, including experience with presentations or seminars, project oversight, and implementation of new services.
Strong time-management skills.
Ability to work collaboratively and independently.
High level of initiative.
Intermediate proficiency with Microsoft Office products, including Word, Excel, PowerPoint, and Outlook.

Responsibilities

Perform testing in accordance with SOPs and cGMP and GLP regulations.
Serve as a subject matter expert for defined areas of BioReliance business.
Apply laboratory techniques and skills to experiments addressing specific problems.
Independently apply basic scientific principles to experiment design and assay development.
Act as Study Director for GLP studies.
Maintain complete and comprehensive records to ensure 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 during testing and routine tasks.
Apply problem-solving and troubleshooting skills.
Communicate deviations, events, progress, and interim results to Study Management.
Lead completion of event records.
Work 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.