Job Description

Company Overview:

Synergy Bioscience is a pharmaceutical contract research organization (CRO) and laboratory testing services provider, serving the FDA-regulated companies. We are currently seekinghighly 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 one or more of the following analytical instruments:

- Boiling/Melting Point Apparatus

- Densitometer

- Potentiometric Titrator

- pH Meter

- Karl Fisher Titrator

-Fourier Transform Infrared Spectroscopy (FTIR Cary 630)

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 a few 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.

• Maintain sample documentation and specifications to ensure product safety, verification, traceability, and Out of Specification Investigation (OOS).
• Perform sample analysis using a few 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:

• Masters degree in chemistry. A higher degree is a plus.
• EP, USP, and JP experience (Required).
• Minimum of 5years of experience in R&D or analytical 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.

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