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Analytical Chemist

2 months ago

Dallas, Texas, United States Synergybioscience Full time

Company Overview:

Synergy Bioscience is a leading pharmaceutical contract research organization (CRO) specializing in laboratory testing services for FDA-regulated entities. We are on the lookout for highly skilled chemists who possess significant experience and can operate independently with laboratory instruments while producing detailed technical reports.

Role and Responsibilities:

The ideal candidate will be proficient in operating, calibrating, and troubleshooting at least one of the following analytical instruments:

  • Inductively Coupled Plasma Mass Spectrometer (ICP-MS)
  • Inductively Coupled Plasma Optical Emission Spectrometer (ICP-OES)
  • Liquid Chromatography Mass Spectrometry (Orbitrap LC-MS/MS)
  • Gas Chromatography Mass Spectrometry (GC-MS)
  • High Performance Liquid Chromatography (HPLC)
  • Total Organic Carbon Analyzer (TOC)
  • Dissolution Apparatus

While expertise in all these instruments is not mandatory, candidates should have substantial experience with at least one of the listed instruments. Responsibilities will also encompass conducting laboratory tests, analyzing results, interpreting data, initiating out-of-specification (OOS) procedures when necessary, and generating comprehensive technical reports. Compliance with standard operating procedures (SOPs), safety protocols, and cGMP/GDP regulatory standards is essential.

Key Responsibilities Include:

  • Maintaining sample documentation and specifications to ensure product safety, verification, traceability, and Out of Specification Investigation (OOS).
  • Conducting sample analysis using at least one of the aforementioned instruments.
  • Executing scientific studies related to pharmaceutical product development, including product stability, formulations, dissolution, leachable/extractable, and test methods.

Qualifications and Experience:

A Bachelor's degree in Chemistry is required.

Experience with EP, USP, and JP standards is essential.

A minimum of 5 to 7 years of experience in R&D chemistry laboratories is expected.

Exceptional technical writing skills are a must.

In-depth knowledge of US FDA regulations and ICH Guidelines is required.

Strong organizational abilities are essential.

Skills Required:

  • Detail-oriented with the capability to multitask and prioritize effectively to meet deadlines.
  • Demonstrated problem-solving skills using logic and reasoning.
  • Proactive in seeking guidance as needed.
  • Self-motivated, capable of working independently and collaboratively while maintaining a focus on quality.
  • Professional demeanor emphasizing teamwork and cooperation.
  • Manual dexterity to operate various laboratory tools and equipment.