Job Description
Job Summary:
- The research we do and the products we develop improve outcomes for patients around the world.
- As an Associate Scientist I at client, 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 safety of our existing and new products.
- We work on products that make a meaningful difference in others’ lives.
- When you join client, you’ll use your analytical approach to identify risks and opportunities for innovation.
Duties and 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 SOP’s and policies on cGMP’s 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.
Education and Experience:
- Bachelors degree in 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.
Knowledge, Skills, and Abilities:
- 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
- This is an on-site position.
Physical Requirements and Work Environment:
- Must be able to hand write and use computers for the majority of the work day.
- 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.