Analytical Chemist

About the Role

As an Associate Scientist/Analytical Chemist, your work contributes directly to making a significant impact on others. We collaborate cross-functionally and lead by influence. As a key part of projects, our research and development team is responsible for delivering results to drive decisions and ensure the safety of our existing and new products. We work on products that make a meaningful difference in others' lives.

Responsibilities

• Conduct critical chemical and physical analyses on finished product R&D stability samples. May also support testing of raw materials, initial, in-process, and final product samples from manufacturing facilities or other R&D initiatives.
• Work under minimum supervision.
• Perform chemical assays requiring precise analytical skills and understanding of chemistry principles.
• Complete all testing, including special project/protocol testing in a timely and appropriate manner to meet project schedules.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGXP, and QSR regulations.
• Collaborate with other functions/departments to solve problems, increase efficiency, improve quality, and provide product support.
• Use sophisticated laboratory instrumentation (HPLC, pH, UV, titrations, Particle, TOC, Flame photometry, etc.) and computer systems to collect and record data.
• Follow, understand, and comply with client SOPs and policies on cGMPs and safety.
• Maintain a clean, safe, and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas.
• Maintain laboratory safety requirements, perform equipment maintenance/calibration, and troubleshoot instrumentation.

Requirements

• Bachelor’s degree in a relevant scientific discipline (e.g., chemistry, pharmaceutical sciences, biology).
• 6 months or more of experience.
• Analytical chemistry instrumentation experience with pH, UV, titrations, Particle, TOC is preferred but not required.
• Must have experience in a regulated environment and strong technical problem-solving skills.
• Must have good oral and written communication skills, strong analytical skills, and be detail-oriented.
• Electronic Lab Notebook experience is preferred but not required.
• Pharmaceutical GMP laboratory experience is desired.
• Empower experience is preferred.
• Must be able to handle multiple tasks concurrently and in a timely fashion.
• Possess relevant laboratory/technical, writing, and computer skills.
• Ability to organize and communicate complex information effectively with managers and peers.

Physical Activities and Requirements

• Must be able to hand write and use computers for the majority of the workday.
• Must be able to transfer materials, mix solutions/product(s), open products, and perform laboratory testing.
• May require standing for extended periods.
• Must be able to lift up to 10 pounds routinely.
• Must not be color blind.

This work is subject to hazards including exposure to chemicals and drug products. Penicillin and Cephalosporin containing products and/or materials may be present in the laboratory.

Schedule

• Monday to Friday (40 hours per week).
• 1st Shift (8:00 AM - 5:00 PM).

About Stefanini Group

The Stefanini Group is a global provider of offshore, onshore, and near-shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence spans countries in the Americas, Europe, Africa, and Asia, serving more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM Level 5 company.