Company Overview:

Synergy Bioscience, a pharmaceutical contract research organization (CRO), provides product development, analytical chemistry, microbiology testing, as well as quality compliance consulting services to the FDA-regulated companies. We are currently seeking 3 (Three) highly qualified R&D scientists with extensive experience in pharmaceutical product development, instrumental analysis, writing technical reports and strong working knowledge of LC-MS.

Role and Responsibilities:

The successful candidate will have knowledge in LC-MS (preferably working with Orbitrap), protocol writing, technical writing, FDA regulation, GMP, GDP and a Team Player. They will analyze results, interpret data, and provide both oral updates and written reports in collaboration with the laboratory manager. Adherence to Standard Operating Procedures (SOPs), safety guidelines, and compliance with current Good Manufacturing Practices (cGMP) regulations will be required in this highly regulated work environment. The individual will also ensure that the R&D lab remains a GMP-compliant and safe working environment.

Key responsibilities include:

• Conducting R&D activities using laboratory equipment such as LC-MS.
• Performing instrument calibration and system suitability checks as needed.
• Writing SOPs, Protocols, and technical reports.
• Following cGMP and GDP work requirements.

Qualifications and Experience:

• EP, USP, and JP experience (Required).
• Minimum of 7 years of experience in pharmaceutical R&D or chemistry laboratory, with a Degree in Science (preferably in Chemistry)
• Exceptional technical writing and communications 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.
• Self-motivated individual, capable of working 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 tools and equipment.