Scientist II - Analytical R&D

Thermo Fisher Scientific•Florence, SC

20h•Onsite

About The Position

The Scientist II conducts laboratory work to ensure products are tested according to operating procedures and that work is performed efficiently and safely. The role uses judgment to adapt and modify assignments and provides routine and non-routine analyses in an analytical chemistry laboratory. Testing includes raw materials, samples, stability samples, production intermediates, and active pharmaceutical ingredients, as well as method development and qualification activities. The position supports internal development and manufacturing operations and requires detailed observation, review, documentation, and communication of results to internal and external stakeholders. Based in Florence, South Carolina, the role is scheduled Monday through Friday, 8:00 a.m. to 5:00 p.m., with flexibility required. The Scientist II performs independent bench-scale experiments and chemical testing, reviews data, investigates unexpected or out-of-specification results, and contributes to analytical methods, validation documents, and SOPs. The role operates in a laboratory and cleanroom environment, follows GMP and safety requirements, and may involve strong odors and required PPE. The position requires the ability to lift up to 40 pounds without assistance and meet the listed ambulatory, standing, dexterity, and visual demands. A bachelor’s degree in chemistry or a related field is required. Five or more years of laboratory and analytical-instrumentation experience are preferred, particularly in GLP or GMP/cGMP settings. Equivalent combinations of education, training, and relevant work experience may be considered. Applicants must pass a comprehensive background check, including drug screening.

Requirements

Bachelor’s degree in chemistry or a related field.
Must pass a comprehensive background check, including drug screening.
Extensive knowledge and understanding of chemistry and analytical instrumental technologies.
Extensive knowledge of qualitative and quantitative chemical analysis.
Extensive knowledge of pharmaceutical-industry quality and regulatory requirements, including pharmaceutical GMPs and descriptive organic chemistry.
Proficiency with HPLC, GC, LC/MS, and dissolution techniques.
Strong problem-solving skills and a logical approach to scientific problems.
Good interpersonal and oral and written communication skills.
Presentation skills to communicate information to customers, clients, and 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, including determination of test reliability, analysis of variance, and correlation techniques.
Ability to work on multiple projects simultaneously.
Ability to lift up to 40 pounds without assistance and meet the stated physical requirements, including prolonged standing, walking, and other periodic movements, as well as dexterity and visual acuity for laboratory and computer work.

Nice To Haves

Five or more years of laboratory experience, preferably in a GLP or GMP/cGMP environment.
Five or more years of experience with analytical instrumentation such as HPLC, GC, CE, ICP, and dissolution apparatus.
Equivalent combinations of education, training, and relevant work experience may be considered.

Responsibilities

Perform routine and non-routine chemical testing and method development or qualification for pharmaceutical raw materials, in-process samples, and active pharmaceutical ingredient samples.
Conduct developmental and validated testing using HPLC, GC, spectroscopy, GC/MS, LC/MS, and traditional wet chemistry methods; train other employees on these techniques.
Assemble and operate bench-scale laboratory equipment and independently carry out experiments.
Perform daily instrument calibrations and verifications, and inspect safety equipment weekly or monthly as required.
Maintain housekeeping standards and a clean, safe work environment, including laboratory work areas, instruments, and testing materials.
Follow cGMP, OSHA, safety regulations, BOPs, SOPs, and laboratory procedures.
Review data collected by other employees and recognize, report, and investigate out-of-specification results or unexpected analytical and product problems.
Document testing and results clearly and accurately, and record and report analyses using prescribed laboratory procedures and systems.
Assist with regulatory documents and communications with outside agencies, clients, and colleagues at other corporate sites.
Write and review analytical methods, validation protocols, validation reports, and SOPs as needed.
Solve problems related to chemical procedures and support functional, technical, and operational excellence and team effectiveness.