Senior Scientist

Technical

• Lead and perform formulation and pre-formulation activities in the development and scale-up of pharmaceutical products including parenterals (solutions and suspensions), and ophthalmic (solutions, suspensions and ointments), and nasal products from bench top to pilot-scale to commercial production.  This may entail technology transfer from other plants as well.
• Applying effective search strategies conduct scientific literature searches and provide critical evaluation of the literature.
• Identify and lead efforts to improve processes/systems while meeting all regulatory and quality requirements.
• Maintain current knowledge of relevant Quality System Regulations and other regulatory requirements related to research and development (product development, design and safety) to ensure compliance in all research, data collection and reporting activities.
• Prepare data summary presentations, compiling data and authoring technical and product development reports for ANDA submissions, and draft responses to FDA deficiency letters related to product development

• Maintain quality checks on safety of the Lab, including biohazards and insure maintenance of the facilities according to Good Laboratory Practices.
• Understand and comply with all Renaissance safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.

Communications 

• Effectively interact with other scientists, project managers and colleagues from numerous functions.  Serve on multi-disciplinary project teams.
• Effectively communicate on results, delays etc., to the upper management and clients

Leadership

• Act as coach, mentor, and technical advisor to junior scientist
• May be sought out by other teams and individuals to offer technical advice.
• Effective planning and delegation of activities to meet critical timelines