Overview:

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on womens health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Role Summary

The Metrologist will report to Quality Control Manager. The Metrologist at Lupin Somerset is expected to lead maintenance, calibration and continuous improvement activities for the R&D, and major laboratory equipment, to establish world-class reliability. This role will work on the development and implementation of procedures, systems, and overall program to support R&D and Commercial operations at Lupin Somerset Site. Assist with investigations due to anomalous or OOC results as required.

Essential Duties and Responsibilities

• Review/approve master Preventive Maintenance/Calibration schedule
• Ensure timely coordination and execution of PM and Calibration schedule for all pieces of equipment and instrumentation used for testing in r laboratory operation, this may include the use of third-party vendors such as manufacturer, manufacturers authorized dealers, or qualified contractors.
• Ensure that PM and calibration records are adequately produced and maintained in accordance with regulatory requirements.
• Maintain instrument inventories with status of PM and calibration dates, manages vendor activities
• Review and continuous improvement of Standard Operating Procedures, forms, templates and any necessary tool to meet customers and regulatory agencies expectations
• Exercise strong problem-solving ability and troubleshooting laboratory instruments
• In support of other groups/departments, executes investigations and CAPA-related activities
• Adhere to cGMP and safety procedures
• Notify management of any observations or deviations
• Ensures all critical instruments are in calibration status.
• Assist in the management and procurement of spare parts and equipment in line with established processes, ensuring availability for planned maintenance and unplanned repair
• Other duties as assigned.

Education & Experience

• Bachelor's Degree in a Scientific Field
• 4-8 years of pharmaceutical industry experience working in a laboratory
• Experience with calibration and maintenance of laboratory equipment such as GC, HPLC, UPLC, dissolution apparatus, FTIR

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting to 15 pounds occasionally. Generally work is performed in a laboratory environment.

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veterans status, or any other classification as required by applicable law.

Search Firm Representatives Please Read Carefully

Lupin USA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms for any current openings at our company without a valid written search agreement in place will be deemed the sole property of Lupin. No fee will be paid in the event a candidate is hired by Lupin as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, No phone calls or emails