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 a highly qualified chemist with extensive experience and the ability to work independently on laboratory instruments and create technical reports.

Role and Responsibilities:

The successful candidate will be in charge of operating, calibrating, and troubleshooting a variety of analytical instruments, including but not limited to ICP-MS, ICP-OES, HPLC, GC, LC-MS, GC-MS, TOC, and dissolution apparatus. While we don't require expertise in all of these instruments, we do expect candidates to have substantial experience with any 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 instruments; such as LC-MS, GC-MC, or ICP-OES (just having the skills to operate and troubleshoot one of these instruments will qualify your resume for consideration).
• Write protocols, technical reports, and SOPs. 
• Develop and perform scientific studies, such as product stability, formulations, dissolution, leachable/extractable, and test methods. 

Qualifications and Experience:

• Bachelor's degree in Chemistry or a related field.
• 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.