Supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying, and sample shipments of the Sterile 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.
Essential Functions: • Ships Samples • Implements corrective actions and preventive actions (CAPAs) to eliminate the root causes of deviations. • Monitors processes to proactively mitigate the risks of deviations and process upset situations occurring. • Troubleshoots issues when deviations and/or process upset situations occur. • Implements continuous improvement projects to drive improved process efficiency and efficacy. Writes and manages department Standard Operating Procedures (SOPs), Batch Production Records (BPRs), Training documents, Protocols, etc. to ensure operational excellence and regulatory compliance. • Contributes to development of methods and processes that meet or exceed the expectations of clients and provides innovation as necessary. • Researches current methodologies. Presents research to internal colleagues and supervisor. • Supports projects at the task level under supervision. May manage projects and timelines at the experiment level. • Assists with implementation of new methodologies and processes. • 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.
Education: • Bachelors of Science in Chemistry, Biochemistry, Biology, Engineering, or related physical science.
Experience: • Typically requires 2 years of scientific experience, preferably in life sciences. If advanced degree, typically requires no previous related experience.
Equivalency: • Equivalent combinations of education, training, and relevant work experience may be considered.
Competencies: • Organized, Independent worker, 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.
Physical Requirements: • Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods