Grifols

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Overview:

This position is in the Bioanalytics Analytical Research group. The selected candidate will be responsible for developing a residual moisture method using NIRS, building a mathematical model, qualifying then validating the NIRS method and model and transferring it to a commercial NIRS equipment in a manufacturing environment. This position is also responsible for providing support on lyophilization development activities characterizing drug substance and drug product. The incumbent will also contribute to the 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.

Primary Responsibilities:

1. The incumbent must have strong organizational and leadership skills
2. The incumbent will be the subject matter expert in NIRS and mathematics requiring minimal assistance using modern instrumental analytical techniques including but not limited to Lab scale NIRS, FTIR, and Karl Fisher.
3. The incumbent will be responsible for characterizing key aspect of the process to manufacturer novel drug substance and drug product
4. The incumbent will author documents for CMC section of regulatory submissions
5. The incumbent will perform data analysis, present results and publish reports.

Requirements:

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. 

1. The Research Scientist level requires a BS with 4+ years or an MS with 2+ or a PhD with 0+ years relevant experience. The Senior Research Scientist I level requires a BS with 6+ years or an MS with 4+ or a PhD with 2+ years relevant experience.
2. The candidate must have experience in the use of modern instrumental analytical techniques, including but not limited to NIRS, FTIR, Karl Fisher...
3. 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.
4. Excellent verbal and written communication skills is essential.
5. Self-starter with strong work ethics and the ability to exercise good judgment.
6. Ability to work independently with minimum supervision.
7. Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
8. Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
9. Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
10. Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).

Occupational Demands:

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.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.

Location: NORTH AMERICA : USA : NC-RTP:USNC0003 - RTP NC-Research Building 85 

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