Sr. Research Scientist I

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.

This Senior Research Scientist I position is in the CMC Product Development, Bioanalytics, Analytical Operations Group. The selected candidate provides analytical testing support and characterization of process development, manufacturing, developmental stability, preclinical, and other R&D studies with minimal supervision. The selected candidate has relevant experience in the development, implementation and validation of new analytical techniques and method transfer activities. The incumbent will be responsible for the Bioanalytics standards and controls program, instrument maintenance and qualification, and instrument software validation.

Note: This is located in Research Triangle Park R&D laboratory.

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 minimum knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

• Must have strong organizational and leadership skills.

• Must have proven written and oral communication skills.

• Demonstrate strong critical judgment, original thought and strategic thinking skills in representation of functional area concerns on cross functional teams.

• Must have considerable scientific knowledge in analytical testing of biologics including but not limited to coagulation assay, enzymatic assays, immunoassay, chromatography, electrophoresis, residual moisture. The awareness and application of applicable regulatory guidance documents for cGXP testing, method validation, and CMC development are preferred requirements.

• Responsible for characterizing key aspects of the process of manufacturing biotherapeutics, reviewing data, and preparing summary slides.

• Strong ability to set and meet deadlines, organize cross-functional meetings, multitask, identify, request, and prioritize resources within or across functional areas based on project needs.

• Proficient with the use of MS Office software

ESSENTIAL DUTIES and RESPONSIBILITIES include the following. Other duties may be assigned.

Developing test methods for characterization and/or release testing of new and existing drug products with minimal guidance

Independently executing and leading method qualification and validation activities

Independently execute characterization testing for various projects including process development and stability

Able to perform testing using such instrumentation such as HPLC, GC, IC, SVP, BCS-XP, Immunonephelometry, Plate Reader, and Karl Fischer

Able to perform testing for potency using ELISA methods

Must have advance written communication skills and excellent oral communication skills and utilize data presentations using power point

Understand root cause analysis, investigation tools and methodologies for data and assays errors

Understand software installation, qualification and validation process

Understand instrument installation, qualification and validation process

Education:

Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology)

PhD +2 yrs

Equivalency: Depending on area of assignment, directly related experience or a combination of directly related education and/or competencies may be considered in place of the stated requirements. Example: Bachelors degree plus 10 years experience, Masters degree plus 6 years experience.

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; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

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

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