Senior Scientist

Merck•Rockville, MD

2d•Onsite

About The Position

As a Senior Scientist, you will provide scientific and technical leadership for assay execution and the implementation of new and innovative service offerings in the biosafety testing space. You will be responsible for the scientific integrity of assigned laboratory work, including making scientific observations, maintaining complete and contemporaneous workbooks and documentation, and ensuring records meet applicable professional, industry, quality, and regulatory requirements. You will maintain a thorough understanding of company testing services, scientific principles, and technical applications relevant to your area of responsibility. Scope of responsibility You will provide scientific oversight for a defined discipline or laboratory within Contract Testing Services. Depending on business needs and formal assignment, you may: Serve as a Team Lead or provide supervisory support. Manage studies and associated scientific deliverables. Serve as Study Director for assigned GLP studies. Perform assays or testing in accordance with applicable GMP/cGMP requirements. Lead assay development, transfer, validation, and continuous-improvement activities. Support the introduction and implementation of new services. When appointed as Study Director for an assigned GLP study, you will fulfill the responsibilities required by applicable GLP regulations, SOPs, and quality systems.

Requirements

Ph.D. in a relevant scientific discipline and 3+ years of scientific or laboratory experience; or Master’s degree in a relevant scientific discipline and 6+ years of scientific or laboratory experience; or Bachelor’s degree in a relevant scientific discipline and 8+ years of scientific or laboratory experience.
At least 5 years of experience with biosafety and product-characterization testing.
Working knowledge of relevant scientific fields and laboratory practices, techniques, equipment, and materials.
Experience with laboratory quality systems and applicable regulatory requirements.
Experience supporting assay development, transfer, validation, or implementation of new services.
Experience leading studies, projects, investigations, or technical initiatives.
Expertise in relevant laboratory techniques, including cell culture, ELISA, flow cytometry, qPCR, and ddPCR.
Ability to interpret scientific data and communicate technical conclusions clearly.
Proficiency with applicable computer programs and laboratory systems.
Strong written and verbal communication skills.
Effective organization and time-management skills.
Ability to work collaboratively and independently.
Demonstrated leadership, coaching, and training skills.
Ability to manage complex technical work while maintaining accurate and compliant documentation.

Responsibilities

Act as a technical expert in defined areas of the BioReliance business.
Lead new-customer assay projects and provide scientific direction throughout the project lifecycle.
Collaborate with client representatives to understand technical requirements and support successful delivery.
Contribute to the technical design of custom assays and provide ongoing scientific support.
Serve as Study Director for assigned studies and support timely study initiation, execution, completion, and reporting.
Ensure testing is performed in accordance with applicable SOPs, GMP/cGMP requirements, GLP requirements, and quality-system procedures.
Participate in or lead assay development, assay transfer, assay validation, and process-improvement activities.
Support the implementation of new services.
Participate in critical-event and laboratory investigations and communicate technical significance to Program Management and clients, as appropriate.
Work with Operations and Quality teams to maintain assays in accordance with the applicable Validation Master Plan and client and regulatory expectations.
Provide scientific coaching, mentoring, training, and technical support to colleagues.
Monitor relevant industry developments and recommend appropriate technical improvements.
Communicate technical developments, new assays, and innovations to Operations, Support, and Technical Support teams.
Promote continuous improvement in quality, scientific performance, compliance, and client service.
Prepare and present scientific data, abstracts, papers, posters, and other technical materials for internal and external audiences.
Ensure assigned assays, methods, and processes remain in a validated state.
Track and trend key assay and production parameters and recommend actions to address adverse trends or emerging issues.
Provide technical support during client and regulatory audits, meetings, teleconferences, and inspections.
Support Sales and Account Management during client visits, as appropriate.
Comply with company health and safety requirements and procedures.
Perform other related duties as assigned.