Laboratory Operations Scientist

🏢 Confidential | Drug Testing Industry (Stealth Mode)

People work LLC is looking for a highly motivated Laboratory Operations Scientist to join our client’s team! The primary role will be to oversee operations of the Assay Development lab, and to implement policies, procedures, and practices to improve efficiency and performance. You will also work cross-functionally to assist and run assay development and engineering integration activities, including verification and validation studies, reagent preparation, as well as data analysis and presentation of results to the team.

This position will report to the VP of Research and Development.

• BS or MS in Molecular Biology, Biochemistry, Chemistry, or related discipline
• 4+ years technical experience in an industry biotech or laboratory setting; experience in a regulated environment preferred (Medical Device, Pharmaceutical, Diagnostics)
• Understanding of laboratory operations, policies, and procedures
• Experience working within a quality system with quality management software
• Experience working in assay development
• High level of attention to detail with strong organizational skills
• Comfortability making decisions in a changing environment
• Specific experience in systems integration and verification and validation studies highly desirable

• Laboratory logistics - keeping inventory, receiving, inspections, taking ownership of lab ops and making the lab more efficient - handle SR1 and both trailers
• Oversee ordering materials and maintenance of inventory and laboratory equipment to ensure that lab is well ordered and stocked
• Prepare and maintain SOPs for laboratory processes / instruments
• Participate in QA/QC activities
• Work with engineers for assay integration
• Attend team meetings to share results and plan projects

• Ability to work independently and as part of an interdisciplinary team to achieve project goals and timelines is required
• Strong verbal, written communication skills, including the ability to communicate efficiently with multiple people both internally and externally
• Ability to prepare and present scientific results to experts

• Documentation and assistance with stability studies
• Develop QC lot release protocols including setting of specifications
• Lead QC activities and investigations
• Assist troubleshooting activities, including root cause analysis, to achieve a timely resolution
• Write and review documentation, work instructions, test reports, SOPs, product specs
• Manage inventory, receiving, inspections related to laboratory activities
• Support materials and laboratory equipment orders and maintenance to ensure lab areas are operating at maximum efficiency
• Drive internal lab process development, management of external laboratory partners, and coordinate activities to support manufacturing initiatives
• Lead lot release activities
• Participate in verification and validation, stability, and clinical studies

• Join a confidential, early-stage drug testing company with meaningful impact on assay development and lab operations
• High ownership of lab efficiency, experiment execution, and documentation
• Opportunity to work closely with scientists, engineers, and quality teams
• Competitive compensation and benefits
• Expected salary range is $54,000 - $93,000 per year, dependent upon experience

🔒 Due to the stealth nature of the organization, additional details will be shared during the interview process.

Apply directly or message me to learn more.