MSAT Technical Writer & Batch Records Specialist

Lupin Pharmaceuticals, Inc.; New Jersey; On-site; USD 70,000 - 95,000; Full time

Job summary

Lupin Somerset is seeking a Technical Operations Scientist to support the Manufacturing Science and Technology (MSAT) team. This role involves authoring technical documents for cGMP operations, preparing manufacturing batch records, and ensuring compliance with regulatory standards.

The ideal candidate will possess a bachelor’s or master’s degree in a scientific discipline and 3+ years' experience in technical writing or benchwork within the life sciences. Strong interpersonal skills and proficiency in SAP are also essential for success in this role.

Qualifications

• 3+ years' experience in benchwork or technical writing for a life science or pharmaceutical organization.
• Excellent grammatical skills and effective oral and written communication skills.
• Detail-oriented, thorough, and methodical with excellent organizational skills.

Responsibilities

• Prepare and maintain Manufacturing and Packaging Batch Records.
• Author protocols, and reports for scientific experiments.
• Train staff on master batch records, protocols, and SOPs.

Skills

Technical writing

Data analysis

Communication skills

Team collaboration

Knowledge of SAP

Education

Bachelor’s or master’s Degree in a scientific discipline

Tools

Microsoft Office Suite

Electronic QMS Systems

Job description

Overview

Lupin is comprised of a fast growing, innovative and robust team of manufacturing, Research and Development and commercial divisions. Together these entities make up the generic and branded U.S. business. Lupin has a significant generic pipeline, and a branded focus on women’s health. Our first Research and Development facility in the US is located in Coral Springs, Florida which focuses on generic and branded orally inhaled and nasal drug products. Somerset, New Jersey is home to one of Fifteen commercial manufacturing sites globally and the only commercial manufacturing facility in the United States for Lupin, as well as additional Research and Development teams. Lupin is prided on being people-focused and centered around how impactful we are with our customers. Dollars are not a measure of success but rather the people we help along the way.

Responsibilities

The Technical Operations Scientist 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 Scientist works with cross-functional teams to prepare scientifically sound documents, and 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), 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

Qualifications

• 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.

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.

The anticipated annual base salary range for this position inNew Jersey is $70,000 to $95,000, plus a discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, the type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states

Physical Requirements

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 a maniufacturing environment.

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