Our client, a creator of a new class of RNAi medicines, has an immediate need for an experienced Lab Operations Lead. The candidate is responsible for supporting PAS functions: sample and reference material management, instrumentation , non-GMP manufacturing, critical reagents inventory, and periodic documentation review for consistency.
- Supervise analytical instrument installation in PAS laboratories: working with vendors on initial new instrument installations, support PM scheduling, track maintenance/repair. Long term: support instruments qualification (IQ/OQ) activities for relocation into a new building.
- Support inventory of critical reagents and materials (e.g., HPLC columns) and controls (e.g., reference standard, impurities standards).
- Support reference standard management by ensuring and organizing aliquot preparation/ dispensing of reference materials as well as delivery of qualified reference materials in accordance with program needs.
- Coordinate shipping of materials (consumables, samples, and standards) to external contract labs, CMOs from company or between company sites on as needed basis.
- Support Safety inspections of PAS laboratories.
- Ensure that laboratory standards are followed by performing daily walk-throughs and supporting periodic audits; support remedial measures to improve lab operation.
- Engage in efficiency improvement activities (e.g., instrument scheduling, critical consumable supply)
- BS in Chemistry, Biology, or related science.
- 4+ years of experience working in industry. Experience with laboratory operations: tracking inventory, samples control.
- Experience with analytical instrument maintenance and qualification performed by vendors.
- Experience with implementation and usage of Laboratory IT systems, e.g., LabWare LIMS.
- Experience with chromatography software such as Empower OpenLabs.
- Knowledge of compliance requirements for early phase development and method qualification.
- Solid communication and writing skills