Lupin Pharmaceuticals · 23 hours ago
Technical Operations Scientist
US-NJ-Somerset
Full-time
Onsite
Mid Level
3+ years expLupin Pharmaceuticals is a fast-growing company focused on generic and branded pharmaceuticals, with a significant emphasis on women’s health. The Technical Operations Scientist will support the Manufacturing Science and Technology team by authoring technical documents and ensuring compliance with regulatory standards at the Somerset facility.
BiotechnologyPharmaceuticalRobotics
Responsibilities
Prepare and maintain detailed Manufacturing Batch Records (MBRs), Packaging Batch Records (PBRs)
Prepare Standard Operating Procedures (SOPs) of MSAT operations
Author protocols, and reports for scientific experiments, engineering studies and process validations. Run trial batches for new as well as commercial inline launches
Author Standard Operating Procedures (SOP’s) for MSAT operations
Collect and analyze data of 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 the products manufactured in the Somerset facility Systematically Organize and manage documents of MSAT in a shared drive
Train the staff on master batch records, protocols and SOPs as needed
Initiate QMS records such as Change Controls, CAPA’s, deviations pertaining to MSAT operations Coordinate with cross-functional departments on timely approval, closure of QMS records
Other duties as assigned
Qualification
Required
Bachelor's or master's Degree in a scientific discipline
3+ years' experience in benchwork or technical writing for a life science or pharmaceutical organization
Must have excellent grammatical skills and effective oral and written communication skills
Adaptable to changes in work duties, responsibilities, and requirements and can manage the workload
Strong interpersonal skills; capability to work as part of a team with formulation scientists and other departments
Working knowledge of SAP, Microsoft Office Suite, Electronic QMS Systems like :- TrackWise, Veeva, etc
Detail-oriented, thorough, and methodical, and excellent organizational and planning skills with the ability to manage and prioritize multiple tasks while still meeting deadlines
Possesses good editorial/proofreading skills and understands and performs well in the process of writing (outlining, drafting, revising, and reviewing)
Excellent organizational skills
Able to perform numerous simple and complex tasks without losing sight of overall objectives
Highly Proficient in Word, PowerPoint, and Excel
The position requires proficient personal computer skills including electronic mail; record keeping, routine database activity, word processing, spreadsheet, and graphics
Company
Lupin Pharmaceuticals
Lupin Pharmaceuticals is a generic pharmaceutical company.
501-1000 employees
H1B Sponsorship
Lupin Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (6)
2023 (2)
2022 (8)
2021 (6)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Bob Hoffman
Chief Commercial Officer (CCO)
Shahin Fesharaki
Global Chief Scientific Officer
Recent News
Catalyst Pharmaceuticals, Inc.
2025-11-06
Business – Baltimore Sun
2025-10-04
Company data provided by crunchbase