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 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. Typically works in a specific scientific area, such as analytical development, cell culture, purification, process validation, formulations, and/or manufacturing technical support. Makes decisions that involve direct application of technical knowledge.
Duties & Responsibilities:
Contributes to development of methods and processes that meet or exceed the expectations from clients and provide innovation as necessary. Researches current methodologies. Presents research to internal colleagues and supervisor. Manages projects at the task level under supervision. May manage projects and timelines at the experiment level. Assists with implementation of new methodologies and processes. Reviews analytical test results and works with internal team to analyze results. Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team objectives. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
Bachelor’s of Science in Chemisrtry, Biochemistry, Biology, or related physical science. Typically requires 2 years of scientific experience, preferably in life sciences. If advanced degree, typically requires no previous related experience. Good knowledge of scientific methodology, preferably related to pharmaceutical research and development. Good knowledge of Good Manufacturing Practices. Good proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills. Effective written, interpersonal, and presentation skills. Ability to work on multiple projects simultaneously. Ability to learn new methodologies and to develop technical solutions.