Scientist III - Analytical Operations

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Scientist III - Analytical Operations

Join our innovative team at Thermo Fisher Scientific Inc. as a Scientist III - Analytical Operations. This unique opportunity allows you to thrive in a world-class environment, providing analytical support that is crucial for our ambitious research and development goals.

Provide analytical support in the Laboratory Operations Department by following standard practices.

Perform analytical testing as assigned for on prototype, CTM (Clinical Trial Material) and Commercial batches supporting development and/or manufacturing operations. Make detailed observations and review, document, and communicate test results.

Essential Functions:

• Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
• Independently carry out HPLC, dissolution, GC, LCMS, advanced instrumentation, and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs).
• Work Proficiency with Empower, NuGenesis, MS Word & Excel Software.
• Perform and/or assist junior scientists in advanced troubleshooting to overcome system suitability failures.
• Author technical documents such as notes to analysts, prepare data summaries and interpret results.
• Recognize and report unexpected or Out Of Specification (OOS) results immediately to the Supervisor and work with the supervisor to complete the resulting investigation.
• Provide expertise for formulation development in terms of analytical methodologies and data interpretation.
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shift work (as required).

Required qualifications

Education:

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

Experience:

• Minimum of 5 years of experience performing analytical testing as assigned for on prototype to commercial batches supporting development and/or manufacturing operations

OR

• Minimum of 2 years demonstrated proficiency as a Scientist II.

Equivalency:

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

Knowledge, Skills and Abilities:

• Advanced understanding of chemistry as it pertains to analytical development and experience with common laboratory equipment and operation. Advanced understanding of chromatographic separations. Knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Demonstrable interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Works well independently and in a team environment. Demonstrated 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, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Physical Requirements:

Must be able to move around lab/office locations, including standing, walking, stooping, kneeling, and crouching for extended periods. Lift and carry light to medium weights (10-35 pounds). Use hands and fingers for typing and grasping. Have good vision for using a keyboard, computer monitor, and equipment. Sit, reach, talk, and hear for extended periods. Wear safety gear as needed.

Work Schedule

• Rotational days/weekends

Environmental Conditions

• Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Loud Noises (Equipment/Machinery), No contact lens allowed; prescriptive glasses will be provided, Office, 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