Grifols Shared Services North America, Inc Senior Research Scientist I/II in Durham, North Carolina
Senior Research Scientist I/II
This position is in the Bioanalytic Analytical Research group. The selected candidate will be responsible for leading a team of scientists to develop, qualify and validate analytical methods necessary to support all phase of new projects. This position is also responsible for characterizing novel drug substance and drug product, designing and executing drug device compatibility studies for clinical studies and contributing to CMC section of regulatory submissions. The incumbent will be expected to work effectively under general supervision and contribute to the team effort to support R&D projects. The ability to analyze and interpret data is essential. Presentation of data to and participation on cross-functional teams are required.
ESSENTIAL DUTIES and RESPONSIBILITIES include the following. Other duties may be assigned.
The incumbent must have strong organizational and leadership skills
The incumbent will be the subject matter expert in particle size analysis and will perform technically more diverse analysis with minimal assistance using modern instrumental analytical techniques including but not limited to Nano Sight, MFI, Archimedes, SE-HPLC Multi angle light scattering, Gel electrophoresis, Western blotting and Isoelectric focusing. Working knowledge of Field Flow Fractionation, Capillary electrophoresis and Circular Dichroism is a plus.
The incumbent will be responsible for characterizing key aspect of the process to manufacturer novel drug substance and drug product
The incumbent will author documents for CMC section of regulatory submissions
The incumbent will perform data analysis, present results and publish reports.
To perform this job successfully, an individual must be able to perform each essential duty with proficiency. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
The candidate must have experience in the use of modern instrumental analytical techniques, including but not limited to Nano Sight, MFI, Archimedes, SE-HPLC Multi angle light scattering chromatography (HPLC, UPLC, GC, and IC), Multi angle light scattering, Gel electrophoresis, Western blotting and Isoelectric focusing...
The candidate must be able to recognize when to modify a standard approach to be more effective and incorporates new technology when appropriate. Frequent communication with personnel from other departments is often necessary to fulfill project assignments.
Excellent verbal and written communication skills is essential.
Self-starter with strong work ethics and the ability to exercise good judgment.
Ability to work independently with minimum supervision.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
Sr. Research Scientist I: Bachelor’s in relevant field, plus 4 years related exp, or master’s degree in relevant field plus 2 years of related experience, or PhD plus 0-2 years of related experience.
Sr Research Scientist II: Bachelor’s in relevant field, plus 6 years related exp, or master’s degree in relevant field plus 4 years of related experience, or PhD plus 2 years of related experience.
Work is performed in a clinical and/or a laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
Req ID: 209809