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 women’s 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 Production Lead will assist the Production Supervisor to execute Production activities, develop, train and coach our Production Operators within our facility according to business needs and requirements.

Essential Duties and Responsibilities

Production Lead: All Operator I & II activities in addition to the following: -

• Verifies dispensed raw materials for batches, stages components and assemble Production equipment for each batch.
• Assisting operators with performing equipment daily usage checks and filling out appropriate logbooks.
• Expert on all Batch Record and SOP instructions while completing all relevant training documentation as required.
• Verifies all operational parameters are documented and steps are performed in the batch record for Manufacturing and Packaging operator entries.
• Ensures all standard in-process testing procedures are carried out accurately by all Production operators.
• Monitoring all Production lines for accuracy, efficiency, stability, conformity and product defects.
• Performs Reconciliation of Manufacturing and Packaging batches.
• Distributing resources to complete necessary tasks within the Production department.
• Works safely as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance, and safety requirements.
• Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.
• Supervises Compounding activities to include delicate equipment setup.
• Performs in-process setup and trouble shoot minor equipment issues.
• Perform in-process adjustments to equipment to maintain operating parameters.
• Assist in coaching and mentoring Level I & II operators as needed.
• All other relevant duties assigned by Production Supervisor.

Education and Experience

•  Knowledge of FDA, cGMP, GDP and SOPs related to job requirements.
•  Ability to read and interpret documents in English such as safety rules, Standard Operating Procedures, batch records, and cleaning procedures.
• Proficient in English to sign and complete batch record documentation.
• Ability to speak and understand English effectively.
• Ability to add, subtract, multiply and divide using different units of measure to include averages of whole numbers, common fractions, and decimals.
• Ability to apply common sense thinking and understanding to carry out detailed written instructions.
• Ability to actively lead, develop and coach team members.
• High school diploma or general education degree (GED)
• Minimum of six months experience and/or training; or equivalent combination of education and experience within a Production cGMP 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, veteran’s status, or any other classification as required by applicable law.

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 up to 35 pounds occasionally. Generally, work is performed in a combination of a corporate and manufacturing environment.

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