Job Title - Staff R&D/MFG Scientist
Requisition ID: 133947BR
 
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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.

Greenville, NC / Drug Product North America

How will you make an impact?

The CM Development Staff Scientist provides project support for the successful launch of products from an innovative continuous manufacturing system. This role supports development teams’ efforts to analyze client products and execute process and formulation development projects. This role will work closely with Operations and Automation personnel to utilize shared resources and equipment.

What will you do? 

· Support risk based formulation and process development, and technology transfer activities from batch to continuous manufacturing; including blending, compression, encapsulation, coating, and feeding studies.

· Design and execute DoE studies to develop a quantitative understanding of the relationship between process parameters, material attributes, and product performance.

· Performing in-depth data analysis on large data sets coming from the continuous manufacturing development processes to distill important process knowledge.

· Work closely with clients to plan and execute activities and advance projects forward.

· Perform risk assessments for products targeted for continuous manufacturing.

· Experience with root cause problem solving utilizing multiple methodologies to determine strong corrective and preventative actions.

· Technical report writing in support of Continuous Manufacturing development.

· Provides technical recommendations to permit product manufacture within regulatory requirements (FDA, EMEA, OSHA, EPA, etc.).

· Promotes a safe work environment for self, employees, customers, and other personnel to reduce personnel and environmental health and safety risks.

How will you get here? 

Education:

· Bachelor’s degree in engineering or physical science is required. A PhD in engineering or physical science is preferred.

Experience

· 1+ years of experience in pharmaceutical drug product development. Late stage development is preferred.

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

Knowledge, Skills, Abilities

· Must be creative, innovative, and possess a high degree of personal motivation.

· Excellent written and oral communication, as well as interpersonal and teamwork skills are essential. Must be able to communicate highly technical information and non-technical information to various levels of personnel throughout production and support areas, as well as with customers.

· Ability to generate scientific technical documents and presentations for scientific and production staff. Experience authoring development reports or regulatory filing documents is desired.

· Some experience using programming for analysis and visualizations of development data is required.

· Must have a sound technical approach to problem solving with a high level of learning ability, plus excellent planning and organization skills.

· Experience with continuous manufacturing in any industry is not required, but is preferred

· Must be able to quickly learn and exhibit a thorough knowledge of the unit operations within continuous manufacturing.

· Must have the ability to work in collaborative, cross-disciplinary teams to achieve the CM program’s goals.

· Due to sensitive proprietary information encountered, must be able to keep this information confidential.

 
Our global team of more than 75,000 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.