Metrology Manager
Advantar Labs - San Diego, CA

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Advantar Labs is a contract provider ofproduct development services for the biotechnology and pharmaceuticalindustries. We are committed toproviding high quality science and high quality service to emerging companiesengaged in drug development.

Our highly experienced team providesexpertise in virtually all dosage forms as well as small molecule, peptide,protein, and oligonucleotide drug molecules. Our GMP-compliant servicesinclude: pre-formulation and formulation development, analytical methodsdevelopment and validation, release and stability testing, compendial analysis,and clinical trial material labeling and packaging.

Advantar Labs currentlyhas an opening for a Metrology Manager to be responsible for the documentation,installation, calibration/verification/qualification, preventive maintenance,and repair of a wide variety of scientific instruments used at Advantar,including but not limited to: HPLC, UPLC, GC, UV/Vis, FTIR, dissolution,particle size analyzers, etc.

Essential Duties andResponsibilities

Calibrates/verifies/qualifiesand performs preventative maintenance on laboratory equipment which include,but is not limited to, HPLC, UPLC, UV/Vis, GC, dissolution, FTIR, particle sizeanalyzers, etc.

Inspects, evaluates,troubleshoots, and repairs laboratory equipment when problems arise.

Documents, reviews, andaudits calibration/maintenance/repair activities of laboratory equipment.

Maintainscalibration/maintenance schedules to keep the Calibration Program up-to-date.

Completes all work in a safe and efficient manner in accordance with cGMP andGLP requirements.

Maintains and archives calibration/maintenance/service records.

Assists in the installation, operation, and performance qualification(IQ/OQ/PQ) of laboratory instruments.

Installs/re-installs, disassembles, cleans and makes necessary modifications tovarious instruments.

Records and reports out-of-tolerance results and any other instrument-relatedissues to the manager and performs corrective actions as directed.

Arranges for vendor service when necessary.

Maintains inventory and researches options on prices and availability of parts.

Works closely with users and external groups to help operate and developtechniques that will meet the needs of the user community.

Participates in writing SOPs, protocols, and instrument validation plans.

Aids in laboratory investigations due to instrument-related issues when needed.

Explores ways that maximize efficiency at lower costs.

Must participate and successfully complete all company training, as required.

Performs other duties as assigned.

Education &Experience

Associate's degree (A.A.) or equivalent from technical school; two to four years related experienceand/or training; or equivalent combination of education and experience.Bachelors degree in Engineering or Chemistry is preferred.Calibration/Maintenance/Service certifications in lab equipment are required. Knowledgeof Waters Empower 3 is required. ExtensiveCalibration/Maintenance/Repair experience on various lab instruments required.Minimum 5 years experience of HPLC, UPLC, GC, Dissolution, UV/Vis, FTIR and/orParticle Size Analyzer calibration, maintenance, and/or repair experience ispreferred. Previous experience in the pharmaceutical or biotech industry is highlydesirable. Must have good communication and technical writing skills.Proficiency in Microsoft Word, Excel, and Outlook and the ability to learnother software applications, as required.