R&D/Manufacturing Scientist II

Thermo Fisher Scientific•Greenville, NC

1d•Onsite

About The Position

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. How will you make an impact? · Technically supports day-to-day operations 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.

Requirements

Bachelor’s of Science in Chemistry, 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.
Equivalent combinations of education, training, and relevant work experience may be considered.

Responsibilities

Executes and writes deviation investigations to identify the root causes of departures from standards and to assess product impact.
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.
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