Scientist I, Research & Development
Thermo Fisher Scientific

Job Info

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Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

Summary:

The Scientist I will conduct laboratory work to assure that products are tested per operating procedures. Ensure that work is carried out in an efficient and safe manner. Applies judgment in making adaptation and modifications on all assignments. Provides routine analyses in an analytical chemistry laboratory following standard practices. Performs analytical methods as assigned for testing on raw materials, samples, stability, production intermediates, and APIs, including method development and qualification activities. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results

Key Responsibilities:

• Consistently aligns with housekeeping standards.
• Maintains a clean and safe work environment including work area, instrumentation, and testing materials.
• Understands and works in compliance with all cGMP, OSHA, and safety regulations, and SOPs.
• Performs cGMP procedures, lab procedures, and SOPs.
• Performs daily instrument calibrations / verifications as required.
• Responsible for weekly/monthly inspection of safety equipment.
• Assembles and operates laboratory (bench scale) equipment and carries out experiments under mentorship of a scientist.
• Conducts routine chemical testing and method development/qualification for pharmaceutical raw materials, in-process samples, and active pharmaceutical ingredient samples by internally developed and compendial test methods.
• Performs developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems.
• Clearly and accurately communicates the results of work by crafting documentation of the testing/analysis and acquired results. Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Assist in preparing regulatory documents and other communications with external agencies and clients.
• Gives information to writing of Analytical Methods, validation protocols, validation reports, and SOPs if needed.
• Collaborate with scientists to resolve problems related to the processing of chemical procedures.
• Ability to drive functional, technical and operational excellence. Ability to encourage and drive team efficiency. Good knowledge of medical terminology, clinical data, and Good Manufacturing Practices (GMP). Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint. Effective written, interpersonal, and presentation skills. Ability to multi-task efficiently.

Qualifications:

• Bachelor's degree in chemistry or related field required.
• Preferred: 1+ years of experience working in a laboratory preferred, (GLP or GMP/cGMP environment preferred)
• Preferred: experience working with analytical instrumentation, such as HPLC, GC, CE, ICP and dissolution apparatus preferred
• Equivalent combinations of education, training, and meaningful work experience may be considered.
• New Graduates are considered! Academic experience considered.

Proficiencies:

Good knowledge and understanding of chemistry and analytical instrumental technologies. Good knowledge of qualitative and quantitative chemical or microbiological analysis. Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry. Good problem solving skills and logical approach to solving scientific problems. Proficiency with HPLC, GC, LC/MS and Dissolution techniques. Good interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees. Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to write standard operating procedures, simple protocols, and reports. Ability to respond to common inquiries or complaints from customers or regulatory agencies. Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

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 an extensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to build an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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