Technical Operations Scientist; Temporary

We are seeking a dedicated and detail-oriented Technical Operations Scientist (Temporary) that reports to the Head of Manufacturing Science and Technology and supports the MSAT team by authoring technical documents required for cGMP operations at the Somerset facility. This temporary role collaborates with cross-functional teams to prepare scientifically sound documentation, assist in process validation activities, and ensure compliance with current regulatory and GMP standards.

It is critical to maintain operational continuity and excellence in GDPs and cGMPs during the leave coverage period. The Somerset facility manufactures and packages solid, powder, and liquid dosage forms.

• Prepare and maintain detailed Manufacturing Batch Records (MBRs) and Packaging Batch Records (PBRs).
• Prepare Standard Operating Procedures (SOPs) for MSAT operations.
• Author protocols and reports for scientific experiments, engineering studies, and process validations. Run trial batches for new and commercial inline launches.
• Collect and analyze data from scientific experiments and commercial batches using statistical tools and methods.
• Support root cause analysis (problem-solving) using lean principles.
• Create and manage master recipes in SAP for manufacturing and packaging of products at the Somerset facility. Systematically organize and manage MSAT documents in a shared drive.
• Train staff on master batch records, protocols, and SOPs as needed.
• Initiate QMS records such as Change Controls, CAPAs, deviations pertaining to MSAT operations. Coordinate with cross-functional departments on timely approval and closure of QMS records.
• Assist lead scientists and engineers in process development and validations.
• Under supervision, communicate progress, needs, requirements, and issues effectively for assigned work and projects to enable leader review and approval, with occasional direction in performing tasks.
• Perform all duties in accordance with cGMPs and standard operating procedures.

• Bachelor’s or Master’s Degree in scientific discipline.
• 3+ years of experience in technical writing and manufacturing for a pharmaceutical organization.
• Excellent grammatical skills and effective oral and written communication.
• Adaptable to changes in work duties, responsibilities, and requirements; able to manage the workload.
• Strong interpersonal skills and the ability to work as part of a team with formulation scientists and other departments.
• Working knowledge of SAP, Microsoft Office Suite, and Electronic QMS systems such as Track Wise, Veeva, etc.
• Detail-oriented, thorough, and methodical, with excellent organizational and planning skills and the ability to manage multiple tasks while meeting deadlines. Strong editorial/proofreading skills and capability in outlining, drafting, revising, and reviewing documents.
• Excellent organizational skills.
• Able to perform numerous simple and complex tasks without losing sight of objectives.
• Highly proficient in Word, PowerPoint, and Excel.
• Proficient computer skills including email, record keeping, routine database activity, word processing, spreadsheet, and graphics.

The anticipated hourly base range for this position in New Jersey is $55.00/hr to $60.00/hr the final salary offered will vary based on factors such as experience, industry, skillset, education, and business needs. Lupin is a multi-state employer, and this salary range may not reflect positions in other states.