Analytical R&D Scientist III
Thermo Fisher Scientific

Job Info

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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; 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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