Technical Operations Associate

Technical Operations Associate

Location:

Somerset, NJ, US

Company:
Lupin

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 role works with cross-functional teams to prepare scientifically sound documents and ensures compliance with current regulatory and GMP standards. This position is pivotal in enabling 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) for MSAT operations.
• Author protocols, 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 products at the Somerset facility.
• Systematically organize and manage documents of MSAT in a shared drive.
• Train staff on master batch records, protocols, and SOPs as needed.
• Initiate QMS records such as Change Controls, CAPAs, and deviations pertaining to MSAT operations and coordinate with cross-functional departments to ensure 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, oral, and written communication skills.

Adaptable to changes in work duties, responsibilities, and requirements, and able to manage workload.

Strong interpersonal skills with the ability to work as part of a team with formulation scientists and other departments.

Detail-oriented, methodical, and excellent organizational and planning skills; able to manage and prioritize multiple tasks while meeting deadlines. Excellent editorial/proofreading skills and familiarity with the writing process (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. Bending, kneeling, crouching, stooping, and crawling may also be required. The position may require lifting up to 15 pounds occasionally. Work is typically performed in an office environment.

Base salary range: The anticipated base salary range for this position is $70,000.00 – $80,000.00 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.

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.