Scientist I - Analytical R&D

Thermo Fisher Scientific

Posted 6 days ago

Full Time

Florence, South Carolina

In Person

Smart Summary

Responsibilities

Conduct routine and developmental analytical testing of pharmaceutical raw materials, in-process samples, stability samples, and active pharmaceutical ingredients using instrumental and wet-chemistry methods. Maintain a safe, compliant laboratory; document and communicate results; identify unexpected or out-of-specification findings; and support method development, qualification, and regulatory documentation.

Qualifications

You have a Bachelor's degree in chemistry or a related field, with a strong understanding of analytical chemistry and instrumental technologies. You are proficient in performing routine chemical testing and method development using various analytical instruments in a GMP/cGMP environment.

Must Have Skills for ATS

HPLC

GC

spectroscopy

GC/MS

LC/MS

wet chemical testing

method development

method qualification

cGMP

GLP

Microsoft Office Suite

analytical instrumentation

Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, 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

How will you make an impact?

The Scientist I conducts 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

Location: Florence, SC

Hours: Mon-Fri 8am-5pm (must be flexible)


What will you do?

  • 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, BOPs and SOPs.
  • Performs daily instrument calibrations / verifications as the need arises.
  • Responsible for weekly/monthly inspection of safety equipment.
  • Assembles and operates laboratory (bench scale) equipment and carries out experiments under guidance 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 obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems.
  • Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
  • Gives information to writing of Analytical Methods, validation protocols, validation reports, and SOPs if needed.
  • Solves problems related to the processing of chemical procedures.
  • Ability to drive functional, technical and operational excellence.  Ability to inspire and drive team effectiveness.  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 work on multiple projects simultaneously.

How will you get here?

*Must be able to pass a comprehensive background check to include drug screening.


Education

  • Bachelor’s degree in chemistry or related field required.
  • New Graduates are considered.

Experience

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


Knowledge, Skills, Abilities

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.


The above statements are intended to describe the general nature and level of the work being performed by people assigned to this job. They are not a comprehensive list of all the duties and responsibilities associated with it.

Competitive wages & Excellent benefits package

  • Review our company’s Total Rewards
  • Medical, Dental, & Vision benefits-effective Day 1
  • Paid Time Off & Holidays
  • 401K Company Match up to 6%(after 1 year)
  • Tuition Reimbursement – eligible after 90 days
  • Employee Referral Bonus
  • Employee Discount Program
  • Recognition Program
  • Charitable Gift Matching
  • Company Paid Parental Leave
  • We will provide the vital equipment for your role including: computer, monitor, keyboard, mouse, etc.
  • We also provide any Personal Protective Equipment you may need including: lab coats, safety glasses, safety shoes, etc.

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific

About Thermo Fisher Scientific 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 complex analytical challenges, increasing productivity 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 delivers an unrivaled 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. For more information, please visit www.thermofisher.com.
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