Scientist, Formulation & Process Development
hace 6 días
Spring Valley
Job Description POSITION: Scientist Formulation and Process Development DUTIES: • Designs, plans, and conducts manufacturing R&D, submission, scale-up batches, and support technology transfer and process validation batches new ANDA product including solid dosage, parenteral (solutions and suspensions) and nasal spray products., • Performs physical and chemical characterization in coordination with analytical teams., • Helps prepare product specifications for in-process, release, and stability purposes., • Collaborates with Analytical, Manufacturing, and other team members to ensure that project timelines are met, • Prepare and execute engineering / evaluation study protocols, prepare process validation protocol, packaging validation protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final evaluation / process validation reports for new and transfer products., • Perform or assist on-site transfer project and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review., • Work on problems of basic to moderate scope. Follow established practices and procedures in analyzing situations or data from which answers can be readily obtained., • Evaluate and troubleshoot basic to mid-level manufacturing / packaging equipment and process issues to eliminate any process deviation., • Identify and apply continuous improvement opportunities to improve production efficiencies, reduce cost of goods, and optimize manufacturing cycle time on existing products., • Conduct training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc. REQUIREMENTS: BS in Pharmacy, Pharmaceutical Science, Chemical Engineering, Medical Informatics or other related fields and 60 months experience as a Process Development Scientist, Formulation Scientist. Chemist, QA Chemist, Pharmacotherapy Consultant or related occupation. OR MS in Pharmacy, Pharmaceutical Science, Chemical Engineering, Medical Informatics or other related fields and 24 months experience as a Process Development Scientist, Formulation Scientist. Chemist, QA Chemist, Pharmacotherapy Consultant or related occupation. SPECIAL SKILLS • Knowledge of Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA, • Analytical test methodology and development for BU, Assay, CU and dissolution profile, etc., • Statistical computations (Cp, Cpk, regression analysis); use of statistical software Hours: 40 hours a week, 9:00 a.m. to 5:00 p.m. Salary: $115,00 base salary/year + std company benefits Job site: 1 Ram Ridge Road, Chestnut Ave, NY 10977