US-FL-FtLauderdale: Scientist in Pharm Tech
Scientist Sr. - Formulation(Pharm Tech)
∑ Carries out responsibilities in accordance with the organizationís policies, procedures, and state, federal and local laws.
∑ Interfaces with Production, Quality, Regulatory Affairs and R&D on process requirements for new and current products.
∑ Provides assistance in troubleshooting to manufacturing and packaging.
∑ Leads multiple on-site transfer projects and new product introductions. Works with project managers to develop and communicate project timelines and status.
∑ Designs experimental plans for process development and design space, scale-up and optimization for new or transferred products. Generates, reviews, and analyzes analytical and statistical data to support the process development work.
∑ Writes protocols and batch records to carry out process development and evaluation work, scale up and bio batch manufacturing (as required) for Abbreviated New Drug Applications (ANDAs) submission to regulatory agency. Plans appropriate analytical testing and stability studies.
∑ Analyzes data to ascertain if it meets related protocol acceptance criteria: writes deviation reports and technical assessments as required.
∑ Performs appropriate documentation, prepares final reports for process development, technology transfer, batch size changes, optimization, and validation studies and ensures they are approved through proper channels.
∑ Maintains appropriate documentation of protocols, reports, and laboratory notebooks as required by Standard Operating Procedures.
∑ Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. Ensures compliance with current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), all Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) regulations and guidelines.
∑ Provides scientific and technical direction and training to junior staff members technicians and operators to ensure project deadlines and performance standards are met.
∑ Collaborates with manager to set priorities and reach objectives. Provides timely feedback to management on the status of various projects.
∑ Conduct performance evaluation for direct reports.
∑ Provides coaching and assistance to direct reports in the areas of disciplinary action, employee training, problem resolution and work assignment delegation.
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