Scientist II, Manufacturing and R&D

Job Description

Job Title: R&D/MFG Scientist II (Scientist II, Manufacturing and R&D)

Location/Division: Greenville, NC | Drug Product North America

DISCOVER IMPACTFUL WORK!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.A DAY IN THE LIFE.

• 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 complete 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.

What will you do? 

• Completes 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 lead 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

KEYS TO SUCCESS

Education:

• Bachelor’s of Science in Chemistry, Biochemistry, Biology, or related physical science.

Experience:

• Bachelors and minimum 2 years of scientific experience, preferably in life sciences; or Advanced Degree.

Equivalency:

• Equivalent combinations of education, training, and relevant work experience may be considered.

Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.