How will you make an impact?
We are seeking a talented and highly motivated candidate to join our research and development team as Lab Manager at our Carlsbad site. This position offers the opportunity to contribute to the product design and development of next-generation sequencing (NGS) systems supporting a broad range of research and regulated applications, including oncology companion diagnostic assays, gene expression profiling, and epigenetics.
What will you do?
The successful candidate will ensure that the NGS lab maintains best-in-class processes and standards for the development of FDA regulated products. As a Lab Manager, you will be the point-of-contact and subject matter expert for all laboratory management-related activities and will partner with cross-functional teams including R&D, Operations, Compliance, Quality and Regulatory to facilitate new product development efforts in both research and clinical settings.
- Perform supply logistics which includes forecasting and procuring materials for R&D demand and inventory control.
- Manage laboratory day-to-day operations including lab organization (5S), laboratory facilities, lab accessibility and security, and safety protocols.
- Ensure adherence to regulatory and quality requirements to be in compliance with lab certifications
- Perform equipment life cycle asset management duties including maintaining instrument calibrations and validations, servicing laboratory equipment, and managing a validated equipment and asset database.
- Participate in site audits as subject matter expert in the areas of lab asset management, equipment servicing and related Quality Management System (QMS) processes.
- Drive the improvement and development of lab management and QMS processes.
How will you get here?
- Bachelor’s degree in Molecular Biology, Chemistry or equivalent disciplines.
- Experience working in ERP systems and working with computer databases.
- Minimum 3 years working in a lab management role
Knowledge, Skills, Abilities:
- Knowledge in clinical lab protocols and laboratory equipment and supplies.
- Able to self-manage and work both independently and in coordination with R&D, Operations, and Quality teams.
- Management Experience – may be required tom manage lab support personnel
- Experience running projects with multi-functional teams while adhering to tight deadlines in a fast-paced environment.
- Good Documentation Practice (GDP) and Good Manufacturing Process (GMP)
- ISO 13485 and 21 CFR Part 820
- 5S Lean
- Practical Process Improvement (PPI)
- Experience as Process Owner for planned or unplanned deviations, non-conformance (NCM), corrective and preventative action procedures (CAPA)
- Document Change Control
- Excellent attention to detail in record keeping and documentation
- Able to communicate at all levels of the organization including managers and senior leaders in the organization.
Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
For more information, please visit www.thermofisher.com