Analytical R&D Scientist III (NMR, IR, KF, HPLC, GC, MS)

As the world leader in serving science, our work is more than something that fills our days – what we do has great purpose. Our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research to clinical to commercial production means you can have a broad and meaningful impact here at Thermo Fisher Scientific. All while working in an environment where you will be supported, valued and rewarded for your performance.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 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 sophisticated analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics, or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an outstanding 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, Patheon, and PPD.

We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. With $1.4 billion invested annually in R&D, our collaborative and diverse teams have the resources they need to drive new discoveries and do cutting-edge research and develop important applications and tools that help millions of lives around the world.

ANALYTICAL R&D SCIENTIST III

Job Description

• Do you have a passion for innovative ideas and ground-breaking discoveries?

• With over $1 billion invested annually in R&D, at Thermo Fisher Scientific you’ll help solve some of the world’s toughest challenges, from giving cancer patients hope, ensuring safe drinking water and helping law enforcement tackle cases through forensics.

• We empower our teams to put science into meaningful action and give our R&D colleagues the autonomy, resources and tools they need to take science a step beyond.

Location/Division Specific Information

• Florence, SC / Drug Substance

How will you make an impact?

• You will develop, investigate, create, transfer, and validate new scientific methodologies used to analyze raw materials, production intermediates, and final products.

• Conducts laboratory work as needed to assure that products are tested per operating procedures.

• Ensure that work is carried out in an efficient and safe manner. Supports internal development and/or manufacturing operations.

• Makes detailed observations and reviews, documents, and communicates test results internally and externally to clients.

• May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development.

• Work on significant technical/scientific project activities to implement strategies and technical solutions that meet client needs and expectations.

• Participate in technical discussions with clients.

• Assist in the design of methods and supports problem solving as needed with leadership and independent judgment.

• Make decisions that frequently require developing new options to solve problems.

What will you do?

• Develop feasible QC-friendly analytical methods for drug intermediates and APIs that meet or exceed the quality requirements from clients.

• Collect reliable data through designed laboratory experiments with accurate, detailed documentation for evaluation, development and troubleshooting.

• Record and analyze scientific data/observations in detail. Summarize and interpret data to draw logical conclusions. Write technical updates/reports. Participate in technical discussions with internal teams and clients.

• Analytical knowledge across many techniques is required including at least NMR, IR, KF, HPLC, GC, and MS.

• Draft, review Methods, Protocol, Reports, Deviations, Change Controls, and Investigative documentation.

• Complete procedures under SOP/cGMP guidelines.

• Evaluate technical package and successfully lead analytical technology transfer.

• Provide timely technical support for Process R&D, Quality Control and other inter-departmental needs.

• Lead projects with minimal supervision; may lead projects, including but not limited to managing process development timelines and deliverables, coordinating analytical development activities.

• Fit in a multidisciplinary team with flexibility to carry out fast-turnaround projects.

• 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, BOPs and SOPs.

• Performs cGMP procedures, lab procedures, BOPs and SOPs.

• Performs developmental and validated test methods using HPLC, GC, spectroscopy, GC/MS, LC/MS, and/or traditional wet chemical testing, and trains other employees on these techniques.

• Provides thoughtful technical review of data collected by other employees.

• Investigates 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 obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems.

How will you get here?

Education

• Master’s degree in chemistry or related field required, or equivalent experience

Experience/Qualifications

• 10+ years of experience working in a laboratory preferred, (GLP or GMP/cGMP environment preferred)

• 10+ years of experience working with analytical instrumentation, such as HPLC, GC, and MS

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

• Knowledge and understanding of chemistry and analytical instrumental technologies

• Strong knowledge of qualitative and quantitative chemical analysis

• Extensive experience of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry

Skills & Abilities

• Ability to drive functional, technical and operational excellence and inspire/drive team effectiveness

• Good knowledge of medical terminology, clinical data, and Good Manufacturing Practices (GMP)

• Ability to work on multiple projects simultaneously

• Excellent interpersonal and communication skills (both oral and written) with the ability to present information to customers, clients, and other employees and write standard operating procedures, simple protocols, and reports

• Ability to read, analyze, and interpret technical procedures and governmental regulations

• 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.

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!