Actalent - Columbus, OH
posted 3 months ago
The R D Scientist I position involves conducting chemical and physical analyses to support the development of a manufacturable multisource pharmaceutical product. This role is critical in providing analytical support for the release of registration materials that are essential for regulatory submissions. The scientist will assist in analytical method validation and transfer activities, ensuring that all assigned analytical tasks are performed in support of product development, registration lot release, and both pre and post regulatory submission activities. The successful candidate will be expected to perform these activities within assigned timelines while adhering to cGXP standards and company practices and procedures. In this role, the scientist will follow work instructions, standard operating procedures (SOPs), and company practices meticulously. Accurate documentation of analytical activities and results is paramount, with an emphasis on timely reporting and maintaining the integrity of data. The scientist will also be responsible for following written analytical procedures and identifying any execution challenges related to analytical methods, providing support for troubleshooting activities as necessary. This position requires a collaborative approach, as the scientist will work closely with a team of other scientists at various levels, while also spending time independently on specific tasks. The work environment is described as a very state-of-the-art laboratory that is clean and compliant with Good Manufacturing Practices (GMP). The dress code is business casual, and the standard working hours are Monday through Friday from 8:00 AM to 4:30 PM.