Provides on the floor customer support in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant. Investigates, validates, and may contribute to new scientific methodologies used to control raw materials, production intermediates, and final products on projects of moderate scope. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development. Works on technical/scientific process/product/project activities to execute strategies and technical solutions that meet client needs and expectations. Assists in the creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary within defined procedures and practices. Makes decisions that involve direct application of technical knowledge.
Leads and writes deviation investigations to identify the root causes of departures from standards and to assess product impact.
Bachelors of Science in Chemistry, Biochemistry, Biology, or related physical science. Graduate degree is preferred.
Typically requires 12 years of scientific experience, preferably in life sciences. If related Master's degree, typically requires 10 years of related experience. If related PhD, typically requires
6 experience. Experience working directly with clients.