Technical Operations Associate

Job Description

The Technical Operations Associate reports directly to the Head of Manufacturing Science and Technology and will support the Manufacturing Science and Technology (MSAT) team in authoring technical documents required for cGMP operations at the Somerset facility. The Technical Operations Associate works with cross‑functional teams to prepare scientifically sound documents and to maintain compliance with current regulatory and GMP standards. This role is pivotal in facilitating excellence in Good Documentation Practices (GDP’s).

The Somerset facility manufactures and packages solid, powder, and liquid dosage form pharmaceuticals.

• Prepare and maintain detailed Manufacturing Batch Records (MBRs) and Packaging Batch Records (PBRs).
• Prepare Standard Operating Procedures (SOPs) of MSAT operations.
• Author protocols and reports for scientific experiments, engineering studies and process validations.
• 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 the products manufactured in the Somerset facility and systematically organize and manage documents of MSAT on a shared drive.
• Train staff on master batch records, protocols and SOPs as needed.
• Initiate QMS records such as Change Controls and CAPAs, and coordinate with cross‑functional departments for timely approval and closure of QMS records.
• Other duties as assigned.

• Bachelor’s or master’s Degree in a scientific discipline.
• 1+ years’ experience in benchwork or technical writing for a life‑science or pharmaceutical organization.
• Excellent grammatical skills and effective oral and written communication skills.
• Adaptable to changes in work duties, responsibilities, and requirements and able to manage workload.
• Strong interpersonal skills; capable of working as part of a team with formulation scientists and other departments.
• Detail‑oriented, thorough, and methodical, with excellent organizational and planning skills and 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).
• Highly proficient in Word, PowerPoint, and Excel.
• Proficient personal computer skills including electronic mail, record‑keeping, routine database activity, word processing, spreadsheet, and graphics.

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 15 pounds occasionally. Generally work is performed in an office environment.

The anticipated base salary range for this position is $50,000.00 – $70,000.00 per year. The actual salary offered will be determined based on the candidate’s qualifications, experience, internal equity, and geographic location, in accordance with New Jersey Pay Transparency requirements. This position is also eligible for a comprehensive benefits package, which may include medical, dental, vision, life insurance, short‑ and long‑term disability, paid time off, paid holidays, and participation in retirement and incentive programs, subject to plan eligibility and terms.

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility

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.