Grifols Shared Services North America, Inc Research Scientist in Durham, North Carolina
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
The incumbent will share the responsibility for the development of the extractables and leachables (E&L) program within Bioanalytics. The selected individual is expected to have a strong background in organic chemistry and a working knowledge of E&Ls.
Primary responsibilities for role:
Ability to independently identify actions required to support departmental objectives.
Execute action plans independently, as part of a team, or as the lead for a departmental team.
Reports project activities to immediate supervisor and within group meetings, capable of presenting technical data at team meetings.
Independently prepares and edits procedures or technical reports, including data interpretation, suitable for regulatory submission.
Independently prepares and effectively communicates technical results in cross-functional team settings.
Independently applies sound scientific principles in development of solutions to complex technical problems.
Capable of mentoring/training junior staff in relevant principles and/or guidelines.
Independently designs, executes, and interprets results for scientifically complex experiments.
Capable of directing others in study execution.
Maintains laboratory facilities in accordance with company policies and industrial best practices.
Provides support for research and developmental studies, clinical or commercial manufacturing as needed.
Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations.
Knowledge, skills, & abilities:
The candidate will perform diverse analytical testing with minimal assistance using modern techniques including but not limited to electrospray ionization mass spectrometry, atmospheric pressure chemical ionization mass spectrometry, and chromatography (HPLC, UPLC, GC, IC). Familiarity with Thermo LTQ-Orbitrap and triple quadrupole-MS systems and the Agilent GC-MS platform is a plus.
The candidate will be involved in the development of qualified and/or validated mass spectrometric methods for small molecule quantification.
The candidate must have excellent written and oral communication skills and be proficient in Microsoft Office.
The candidate is expected to identify analytical techniques in the literature, adapt them for use in the laboratory, and to develop new methods for analyte identification and quantification.
The candidate must become an expert in extractable and leachable regulatory requirements. The individual will support our E&L program by performing risk assessments for materials that contact our products and designing and managing our E&L studies according to current regulatory guidance.
The candidate will perform accurate technical/GXP review of other operators work and can interpret/ understand trends in data.
The candidate will contribute to report writing and perform data analysis.
PhD + 0-2 years of relevant experience. Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology).
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of 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: 466947