Peoplework LLC · 19 hours ago
Laboratory Operations Scientist
San Francisco Bay Area
Full-time
Onsite
Mid Level
$54K/yr - $93K/yr
4+ years expPeoplework 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, implementing policies and procedures to improve efficiency and performance while working cross-functionally on assay development and engineering integration activities.
Human Resources
Responsibilities
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
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
Qualification
Required
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
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
Preferred
Experience in a regulated environment preferred (Medical Device, Pharmaceutical, Diagnostics)
Specific experience in systems integration and verification and validation studies highly desirable
Benefits
Competitive compensation and benefits
Company
Peoplework LLC
2-10 employeesFunding
Current Stage
Early StageCompany data provided by crunchbase