Principal Scientist, Chemistry
Perform analytical chemistry testing to support the medical device and pharmaceutical industries. Provide technical expertise relating to chemistry testing and experimentation. Assist in building and maintaining technologies necessary to serve Analytical Chemistry clientele. Responsible for assisting in department compliance with applicable regulatory guidance documents and QA policies and directives. Responsible for interfacing with clients and building external scientific and client relationships.
Essential Duties and Responsibilites
• Develop or supervise experimental designs to execute ISO 10993-18 testing on diverse medical devices
• Conduct routine and advanced analytical chemistry testing, utilizing instrumentation such as LC-MS, GC-MS, HPLC, and GC
• Provide scientific expertise for the interpretation and evaluation of results
• Prepare, review and approve GMP protocols and reports
• Review data generated by other Analytical Chemistry personnel
• Develop, validate, and document analytical methods
• Interface with clients
• Identify opportunities to improve workflow in lab
• Troubleshoot problems and provide and implement solutions to problems encountered
• Initiate and implement preventative and corrective actions
Qualification Requirements/Training Programs
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Education, Expertise, and Experience
EDUCATION and/or EXPERIENCE
• PhD in scientific field with minimum 3 years of experience or equivalent combination of education and experience
• Strong expertise and experience with instrumental spectroscopy and other analytical techniques including, method development, and structure elucidation
• Special consideration will be given to candidates with 10993-18 testing and mass spectroscopy elucidation experience.
• Knowledge in analytical chemistry bench-top techniques
• Knowledge of analytical instrumentation such as HPLC and GC with the ability to analyze and interpret chromatographic data
Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint) and programs specific to lab instrumentation.
Must be able to effectively communicate verbally and in writing with management, co-workers and clients. Read and comprehend work instructions/SOPs and protocols and write clear, concise reports.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and manipulate equations involving exponential and logarithmic functions. Must know basic statistical analysis and have the ability to perform statistical calculations. Must be able to use metric.
Other Skills and Abilities
Ability to analyze, interpret and draw conclusions from data and exhibit problem solving and trouble shooting skills. Demonstrate significant attention to detail in testing and documentation practices.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to stand, sit and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear. The employee must frequently lift and/or move up to 30 pounds and occasionally lift and\or move up to 50 pounds. Specific vision abilities required by this job include close, color, and peripheral vision and the ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Combination of office and laboratory settings (with typical laboratory risks) where moderate noise levels may exist. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. LOCATION Rush, New York TRAVEL Minimal DISCLAIMER This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.