Scientist I, Analytical Operations

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Scientist I – Analytical Operations

Summary:

At Thermo Fisher Scientific Inc., we offer an outstanding opportunity to become a part of our world-class team. As a Scientist I in Analytical Operations, you will provide critical analytical support within our Laboratory Operations Department. Your work will be instrumental in supporting prototype, Clinical Trial Material (CTM), and Commercial batches, contributing to our ambitious goal of advancing scientific research and development.

Essential Functions:

• Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) principles.
• Independently carry out HPLC, dissolution, and physical testing analyses following established Analytical Methods & Standard Operating Procedures (SOPs).
• Demonstrate proficiency with Empower, NuGenesis, MS Word, and Excel software.
• Perform basic troubleshooting to resolve system suitability failures successfully.
• Recognize and report unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conduct laboratory investigations under direction.
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shift work as required to ensure flawless operations.

Required qualifications

Education:

• B.Sc. in chemistry or a related field, or equivalent experience.

Experience:

• Proven experience with common laboratory equipment and operations.

Equivalency:

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

Knowledge, Skills, and Abilities:

• Solid understanding of basic chemistry and chromatographic separations.
• Knowledge of qualitative and quantitative chemical or microbiological analysis.
• Awareness of quality and regulatory requirements in the pharmaceutical industry.
• Strong problem-solving skills and a logical approach to scientific challenges.
• Excellent interpersonal and communication skills, both oral and written.
• Ability to read and interpret technical procedures and governmental regulations.
• Capacity to apply mathematical operations to determine test reliability, analyze variance, and perform correlation techniques.
• Demonstrated ability to work both independently and collaboratively in a team environment.
• Computer proficiency with Microsoft Office programs.
• Proficiency in the English Language.

Standards and Expectations:

• Follow all Environmental Health & Safety Policies and Procedures.
• Work collaboratively with fellow team members, modeling positive teamwork principles and partnering to meet project and departmental objectives.
• Strictly adhere to Patheon quality systems SOPs and Good Manufacturing Practice (GMP).
• Maintain workspace in a clean and orderly fashion.
• Actively engage in departmental systems to ensure smooth and efficient workflow.
• Be client and patient-conscious at all times.
• Understand Key Performance Indicators and strive to improve team performance by identifying areas for system improvements and engaging in problem-solving.
• Model positive thinking and openness to change, motivating the team to adapt to new priorities and methods.
• Proactively identify areas for improvement in procedure execution.
• Communicate risks to timelines proactively.
• Consistently strive to improve skills and knowledge in the related field.

Physical Requirements:

Physical coordination and ambulatory skills are necessary for moving around lab/office locations. You should be comfortable standing, walking, stooping, kneeling, and crouching for long periods. You should also have good arm and hand dexterity and be able to use a keyboard and computer monitor. Safety equipment may be required, including glasses, shoes, a lab coat, gloves, an apron, and occasionally a respirator.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Job requirements are stated briefly to align with legal obligations in each country.