Research Scientist II

$89,100 - $95,000/Yr

Luitpold Pharmaceuticals - Brea, CA

Full-time - Mid Level

Brea, CA

Merchant Wholesalers, Nondurable Goods

About the position

The Research Scientist II at American Regent, Inc. plays a crucial role in the development and validation of analytical methods for pharmaceutical products. This position involves executing activities related to method validation in compliance with international guidelines such as ICH and USP/EP. The scientist will conduct sample testing using various analytical techniques including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and other laboratory instruments to support formulation and process development. The role requires a strong understanding of cGLP/cGMP regulations and the ability to prepare detailed protocols and reports for method validation and analytical testing. In addition to method development, the Research Scientist II will be responsible for organizing and preparing samples for analysis by external laboratories, providing training to new scientists on analytical methods and instruments, and troubleshooting analytical equipment. The position also requires adherence to safety regulations and company policies, ensuring compliance with GMP guidelines. The scientist will work collaboratively within an interdisciplinary team, contributing to the overall success of product development and regulatory filing processes. This role is essential for maintaining the high standards of quality and compliance expected in the pharmaceutical industry, and it offers an opportunity to engage in meaningful work that impacts patient care.

Responsibilities

• Conduct analytical studies in support of formulation development, process development, process scale-up, and regulatory filing.
• Organize and prepare samples for analysis by external laboratories.
• Develop and validate analytical methods for raw materials, in-process and finished products under cGLP/cGMP, ICH, USP/EP Guidelines.
• Prepare protocols and reports for method validation, analytical test methods, technology transfer, and stability studies.
• Provide training to new scientists to perform analytical methods and operate instruments.
• Troubleshoot and maintain analytical equipment.
• Observe and maintain compliance with safety regulations, cGLP/GMP guidelines, and company policies and procedures.
• Perform any other tasks/duties as assigned by management.

Requirements

• BS or MS degree in pharmaceutical science, chemistry, biology, or a life science-related field.
• 4+ years of method development and validation experience in the pharmaceutical industry.
• Experience with analytical instrument techniques such as UV, HPLC, and GC.
• Experience in analytical method development and validation for assay and impurities.
• Extensive experience in protocol writing, technical report creation, and lab investigations.
• Good working knowledge of HPLC and GC techniques and troubleshooting skills.
• Ability to multi-task, focus on priorities, and solve problems effectively.
• Ability to work effectively within an interdisciplinary team setting, both independently and collaboratively.
• Good knowledge of GMP Compliance, ICH, EP/USP Guidelines.
• Excellent computer skills (Excel, Word, PowerPoint, etc.), documentation, and technique writing skills.
• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules, and operating manuals.

Benefits

• Profit sharing
• Health insurance
• Paid time off
• 401(k) matching
• Life insurance