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 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 and 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 method development 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. * *

1. The position requires a degree in a relevant area of study (e.g., Biology, Biochemistry, Chemistry, Toxicology). Master's plus 3 years of experience, Bachelor's plus 5 years of experience.

2. The candidate must have experience using modern instrumental analytical techniques, including plate reader, pH meter, balance, making solutions, single and multi-channel pipetting.

3. The candidate should have experience in designing quantitative methods and method qualification/ validation.

4. Experience with protein analytical techniques such as enzymatic assays (e.g. coagulation), cell-based assays, gel electrophoresis, and Western blotting is a plus.

5. Experience working in a regulated environment and proficiency with statistical software such as SAS JMP is a plus.

6. The candidate must be able to recognize when to modify a standard approach to be more effective and incorporates new technology when appropriate.

7. Frequent communication with personnel from other departments is often necessary to fulfill project assignments.  Excellent verbal and written communication skills are expected.

8. The candidate must have a strong work ethic, the ability to exercise good judgment and to work independently with minimum supervision, and be proactive, results oriented, and have strong attention to detail.

9. Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.

10. Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.

11. Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.

     

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. Repetitive hand movement of both hands with the ability to make fast, simple, repeated 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.

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.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 519108

Type: Regular Full-Time

Job Category: Research & Development