Technical Operations Scientist

Job Description

Lupin is a fast-growing, innovative organization with strong manufacturing, R&D, and commercial divisions supporting its U.S. generic and branded business, including a focus on women’s health. Its U.S. R&D facility in Coral Springs, Florida specializes in orally inhaled and nasal drug products, while Somerset, New Jersey hosts its only U.S. commercial manufacturing site along with additional R&D teams. Lupin emphasizes a people-focused approach, measuring success by the impact on patients rather than financial metrics.

The Technical Operations Scientist reports to the Head of Manufacturing Science and Technology (MSAT) and supports cGMP operations at the Somerset facility. This role involves preparing scientifically sound documentation, ensuring compliance with regulatory and GMP standards, and promoting Good Documentation Practices (GDP). The facility manufactures solid, powder, and liquid pharmaceutical dosage forms.

• Preparing and maintaining Manufacturing and Packaging Batch Records (MBRs/PBRs)
• Authoring SOPs, protocols, reports, and validation documents
• Supporting trial batches and commercial product launches
• Collecting and analyzing data using statistical methods
• Assisting in root cause analysis using lean principles
• Managing master recipes in SAP
• Organizing MSAT documentation
• Training staff on batch records and SOPs
• Initiating and managing QMS records (Change Controls, CAPAs, deviations)
• Coordinating with cross-functional teams for timely QMS completion
• Performing additional assigned duties

Qualification and Experience

Competencies