R&D Scientist I
About the role
The R&D Scientist I conducts chemical and physical analyses to support the development of manufacturable multisource pharmaceutical products. This role provides analytical support for the release of registration materials used in regulatory submissions and assists with analytical method validation and transfer activities. The scientist performs assigned analytical tasks within established timelines, ensuring full compliance with cGXP standards, standard operating procedures, and internal practices, while maintaining accurate, timely, and reliable documentation. This is a Contract to Hire position based out of Columbus, OH, working in a state‑of‑the‑art, very clean GMP laboratory environment organized into teams of Scientists I, II, and III. Business casual attire is expected, and the environment emphasizes teamwork, internal promotion, and ample opportunities for professional growth within pharmaceutical manufacturing and development.
Responsibilities
- Perform sample preparation, including handling and processing of materials for analytical testing.
- Prepare and weigh standards accurately to support quantitative analytical methods.
- Carry out dilutions and wet chemistry techniques in accordance with written procedures.
- Conduct titrations, pH measurements, and viscosity testing as part of physical and chemical analyses.
- Operate and maintain analytical instrumentation such as HPLC, NGI, and gas chromatography systems, following established methods and protocols.
- Support admitted dose and related pharmaceutical testing activities to ensure product quality and consistency.
- Execute chemical and physical testing of organic materials in support of product development and new product initiatives.
- Provide analytical support for registration lot release and pre- and post-regulatory submission activities.
- Follow work instructions, SOPs, and company practices to perform analytical tasks in a compliant manner.
- Document all analytical activities, observations, and results accurately, in a timely fashion, and right‑first‑time, ensuring data integrity.
- Adhere to written analytical procedures and identify execution challenges in analytical methods.
- Participate in troubleshooting activities to resolve method or instrument issues and improve analytical performance.
- Work collaboratively within a team of scientists at different levels to accomplish assigned tasks and project objectives.
- Manage multiple analytical tasks in a fast‑paced environment while maintaining quality and compliance.
- Use scientific judgment and professional competency when