Scientist III, Manufacturing Sciences

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Location/Division Specific Information: Greenville, NC/Drug Product Division. Shift: 8:00am4:30pm, Monday through Friday with overtime as needed. NOTE: Some off-hours may be required. Discover Impactful Work: As an R&D/Manufacturing Scientist III, you will support sterile manufacturing processes for both traditional aseptic and isolator manufacturing environments. Responsibilities include scaling new processes, supporting product validation and post-approval qualifications, and supporting routine operations to ensure timely product release. You will serve as the technical representative on client projects and collaborate with analytical, quality, and project management teams to drive successful process development, commercialization, and day-to-day operations. Key Responsibilities:

• Collaborate with cross-functional teams to support product and process development in commercial manufacturing.
• Lead technical planning and client interactions, ensuring alignment across multiple projects.
• Apply risk-based approaches to process scale-up and commercialization, developing mitigation strategies.
• Prepare batch records, protocols, and reports for development, validation, and routine production.
• Act as technical steward for assigned products, supporting routine manufacturing.
• Investigate new scientific methodologies for controlling raw materials, intermediates, and final products.
• Implement strategies and technical solutions to meet client needs.
• Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines.
• Conduct product investigations and develop CAPAs.
• Analyze deviation trends and provide insights for continuous improvement.

Preferred Knowledge/Skills:

• Knowledge of scientific methodology and development in the pharmaceutical industry.
• Understanding of Good Manufacturing Practices.
• Proficiency in Microsoft Office Suite.
• Excellent critical thinking, problem-solving, and technical writing skills.
• Effective communication and presentation skills, with the ability to lead technical discussions.
• Ability to evaluate data, develop technical solutions, and make recommendations.
• Knowledge of regulatory requirements (e.g., FDA, EMA, ISO) and industry standards.
• Proficiency in quality management systems (QMS) and relevant software tools.

Qualifications: Bachelors Degree required ideally in Chemistry, Biology, or a related physical science with a minimum of 5 years of relevant experience. An equivalent combination of education and relevant experience may be considered. Physical Requirements:

• Stand for extended periods.
• Handle chemicals and operate various laboratory equipment.
• Lift up to 40 pounds without assistance.
• Adhere to all Good Manufacturing Practices (GMP) Safety Standards.
• Work in cold room/freezer environments (-22F/-6C).
• Work in laboratory and office settings.
• Use personal protective equipment (PPE) such as safety glasses, gowning, gloves, lab coat, and ear plugs.

Benefits: We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!