Sr. Research Scientist I
GrifolsAbout the role
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 Analytical Development group within Bioanalytics. The selected candidate will be responsible for leading efforts to develop, qualify, validate and implement analytical methods (Biochemical, Immunological, Enzymatics and cell-based Methodology) necessary to support all phases of Drug development projects. This position is also responsible for characterizing process intermediates and drug products for current and novel biotherapeutics. The candidate will be responsible for authoring protocol and reports and contributing to CMC section of regulatory submissions. The ability to analyze, interpret data (including troubleshooting) and relationships in data across different analytical techniques, is essential. Presentation of data to and participation on cross-functional teams is required. May lead cross functional teams or represent functional area on cross functional teams. The incumbent will be expected to work effectively under general supervision and contribute to team efforts to support CMC Development projects.
Note: This is located in Research Triangle Park R&D laboratory.
ESSENTIAL DUTIES and RESPONSIBILITIES include the following. Other duties may be assigned.
- Must have strong organizational and leadership skills.
- Must have advanced written and oral communication skills.
- Demonstrate strong critical judgment and strategic thinking skills in representation of functional area concerns on cross functional teams.
- Effectively communicates functional area and departmental technical data in cross-functional settings.
- Must be a subject matter expert in the development, validation and implementation of immunoassay and analytical software for non-linear regression models (e.g. 4 and 5 parameter logistic models).
- Must have considerable knowledge in professional field of specialization, including the awareness and application of applicable regulatory guidance documents.
- Responsible for characterizing key aspects of the process to manufacture biotherapeutics.
- Strong ability to set and meet deadlines, multitask, identify, request, and prioritize resources within or across functional areas based on project needs.
- Independently applies sound scientific principles in development of innovative solutions to complex technical problems.
- Maintains laboratory facilities in accordance with company policies and industrial best practices.
- Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations.
- Proficient with the use of MS Office software
Requirements:
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. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.
- The po
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