Company Overview:

Synergy Bioscience is a pharmaceutical contract research organization (CRO) and laboratory testing services provider, serving the FDA-regulated companies. We are currently seeking ten (10) highly qualified chemists with extensive experience and the ability to work independently on laboratory instruments and write technical reports.

Role and Responsibilities:

The successful candidate will operate, calibrate, and troubleshoot 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)

- Total Organic Carbon Analyzer (TOC)

- Dissolution Apparatus

While we don't require any of the applicants to have expertise in all of these instruments, we do expect candidates to have substantial experience with at least one of the above-mentioned instruments they claim to be familiar with. Duties will also include conducting laboratory tests, analyzing the results, interpreting data, initiating out-of-specification (OOS) procedures when necessary, and generating technical reports. Adherence to standard operating procedures (SOPs), safety guidelines, and cGMP/GDP regulatory requirements is mandatory.

Key responsibilities include:

• Maintain sample documentation and specifications to ensure product safety, verification, traceability, and Out of Specification Investigation (OOS).
• Perform sample analysis using at least one of the instruments mentioned above.
• Perform pharmaceutical product development scientific studies, such as product stability, formulations, dissolution, leachable/extractable, and test methods.

Qualifications and Experience:

• Bachelor’s degree in chemistry.
• Minimum of 5 - 7 years of experience in R&D chemistry laboratory.
• Exceptional technical writing skills.
• In-depth knowledge of US FDA regulations and the ICH Guidelines.
• Strong organizational skills.

Skills Required:

• Detail-oriented with the ability to multitask and prioritize tasks to meet deadlines.
• Demonstrated ability to use logic and reasoning to solve problems.
• Proactive in seeking direction as required.
• Self-motivated individual, capable of working hard both independently and in a team, while maintaining a focus on quality.
• Professional attitude emphasizing teamwork and cooperation.
• Manual dexterity to operate a variety of laboratory tools and equipment.