What are the responsibilities and job description for the Scientist position at Scientific Search?
Scientist
Location; Delmar, MD (relocation offered)
Position Summary
Coordinates activities related to the enhancement of existing products/processes and implementation of new product launches. The incumbent is required to directly monitor and is involved in the engagement of Scale-Up and Post approval changes to support existing products. The Scientist renders technical expertise and plan activities for new product technology transfer from development/ other sites, Scale-up and manufacturing of ANDA submission batches. The position provides hands on developmental work during all processes and monitors the manufacturing of all batches and related documentation.
Essential Functions
Experience and Qualifications:
Location; Delmar, MD (relocation offered)
Position Summary
Coordinates activities related to the enhancement of existing products/processes and implementation of new product launches. The incumbent is required to directly monitor and is involved in the engagement of Scale-Up and Post approval changes to support existing products. The Scientist renders technical expertise and plan activities for new product technology transfer from development/ other sites, Scale-up and manufacturing of ANDA submission batches. The position provides hands on developmental work during all processes and monitors the manufacturing of all batches and related documentation.
Essential Functions
- Responsible for enhancements for continuous improvement of existing products/ processes of solid oral dosage forms.
- Responsible for transfer of technology to manufacturing department during the process validation of submitted/approved products
- 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.
- Transfer of technology for new products from the development site/client site to manufacturing site, particularly generic solid dosage forms.
- Responsible for scale-up of approved products.
- Renders technical support for commercial products during routine manufacturing.
- Prepares and reviews all documentation required for the above activities e. g write strategy documents, related investigations and deviations, standard operating procedures, protocols, reports, etc.
Experience and Qualifications:
- Education
- Educational level required is a Bachelor’s degree; MSA preferred, in Pharmaceutical Sciences, Industrial Pharmacy or related science discipline.
- Industry Experience Required
- Five (5) years of pharmaceutical experience with solid oral dosage forms in Product development and/ or Process development in a US/ EU cGMP settings is required.
- Experience with ANDA submission/ approval process, past experience writing regulatory documents and technical reports is required.
Please email Kiera@ScientificSearch.com and reference Job#17633
Additional jobs can be found at www.ScientificSearch.com
Additional jobs can be found at www.ScientificSearch.com
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