|General Summary of the Position
Reporting to the Manager, Technical Services, and will coordinate activities related to enhancement of existing products/processes and implementation of new product launches. Direct monitoring and engagement of Scale-Up and Post approval changes to support existing products. Render Technical expertise and plan activities for new product technology transfer from development/ other sites, Scale-up and manufacturing of ANDA submission batches. Hands on developmental work during the all processes. Monitor manufacturing of batches and all related documentation.
1. Responsible for enhancements for continues improvement of existing products/ processes of solid oral dosage forms.
2. Responsible for transfer of technology to manufacturing department during the process validation of submitted/approved products
3. Directly involved in successive phases of developmental and transfer activities including production of research, Scale-Up, Exhibit Registration for ANDA submission, component changes and process validation batches in a cGMP environment.
4. Transfer of technology for new products from the development site/client site to manufacturing site, particularly generic solid dosage forms
5. Responsible for scale-up of approved products.
6. Render Technical support for commercial products during routine manufacturing.
7. Prepare and review all documentation required for the above activities e. g write strategy documents, related investigations and deviations, standard operating procedures, protocols, reports, etc.
1. Educational level required is a Bachelors degree; a MS. is preferred in Pharmaceutical Sciences or related field.
2. At least 8+ years of pharmaceutical experience with solid oral dosage forms is required.
3. Demonstrated Knowledge and understanding of solid oral dosage manufacturing processes and equipment.
4. Demonstrated knowledge and working understanding of basic concepts of Good Manufacturing Practices (GMP) is required.
5. Demonstrated experience with process validation, cleaning validation, regulatory documentation, Product development / formulation and pharmaceutical manufacturing in and USFDA setting is required.
6. Demonstrated skills in Scale-up / Technology Transfer projects.
7. Experience with regulatory submission/ approval process, past experience writing regulatory documents and technical reports is required.
8. Good subject knowledge and problem solving skills required.
State or Province