Responsibilities of a Chemist includes:
- This position is considered full time (40 hours a week on average, sometimes more) position. Follows all policies, procedures, SOPs, cGMPS, Work Instructions, and supervisor instructions.This duty is performed daily, about 100% of the time.
- Formulation research and development of assigned new products.
- Method development, method validation, write-up, procedure writing, ensuring correctness of
monographs and trouble-shooting of assigned projects.
- Evaluate suitability of new raw materials for new or existing products.
- Provide analytical methods for new raw materials and/or new finished products.
- Writing method validation protocols and reports.
- Responsible for performing analytical testing per cGMP and cGMP documentation guidelines.
- Responsible for preparing laboratory batches.
- Technical Transfer of validated methods from Product Development to Quality Control.
- Responsible for the stability studies on new products.
- Basic maintenance and use of and other equipment in the product development laboratory such as the pH meter, density meter, centrifuge, shakers, dissolution apparatus, etc.
- Monitor exhibit batches during the manufacturing process.
- Assists in the scale-up of new or modified formulations to production-size batches and troubleshooting in Manufacturing.
- Provides Regulatory Affairs with required documentation for ANDA submissions.
- Provides the Master Formula including manufacturing directions for new or modified products as assigned.
- Assists with training of chemists.
- Responsible for ordering laboratory supplies for assigned projects.
- Accountable for the accuracy and timeliness of work, attention to detail, and adherence to test method monograph/specifications. For following applicable Standard Operating Procedures, including all safety procedures and policies. For working safely in an effective work team.
Job Requirements of a POSITION NAME:
- 4-year degree in Chemistry, Biology or another related field
- Experience working in a lab
- Strong attention to detail