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.

Summary:

The position will be responsible for development and execution of procedures to quantify viral reduction as applied to processes for the manufacture of plasma-derived or genetically engineered recombinant products. Experiments will involve performing scale-down models of manufacturing processes and testing viral clearance capacities. This individual may work at the laboratory bench and have primary or shared responsibility for a project. The candidate should have excellent problem-solving skills and be able to propose solutions to complex problems using state of the art information from the scientific literature.

The position also may have responsibility for assisting in design of protocols for outsourced/ contracted viral clearance studies and managing these studies with a high level of oversight.

A possible additional component of the position may be assisting in preparation of pathogen safety risk assessment reports for manufacturing incidents with an impact on pathogen reduction steps in our manufacturing processes, inquiries from Regulatory agencies, and other topics.

Primary Responsibilities for Role:

• Responsible for independently identifying actions required to support departmental objectives.

• Execute action plans independently, as part of a team, or as the lead for a departmental team.

• Responsible for representing the functional area or capable of leading a cross-functional team to achieve identified objectives.

• Independently prepares and critically edits procedures or technical reports of a complex nature, assimilating information across functional areas, suitable for inclusion in IND, BLA, or equivalent regulatory submission.

• Develops creative, novel programs to meet departmental objectives.

• Leads others in problem-solving efforts.

• Advanced ability to creatively apply scientific principles in problem solving in potentially novel areas.

• Mentors/trains staff in relevant principles and/or guidelines.

• Responsible for serving as technical consultant within functional area or site.

• Independently designs, executes, and interprets results for novel and scientifically complex study programs

• Mentors others in experimental design

• Responsible for directing other 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, and Abilities:

• Strong ability to set and meet deadlines, multitask, as well as identify, request, and prioritize resources based on project needs.

• Demonstrates strong critical judgment and strategic thinking skills in representation of functional area concerns on cross functional teams.

• Capable of representing the functional area on a cross-functional team and presenting technical data at team meetings.

• Can identify and request needed resources within or across functional areas.

• Capable of supervising up to eight scientific personnel.

• Effectively communicates functional area and departmental results in cross-functional settings.

• Must have advanced written and oral communication skills.

• Independently applies sound scientific principles in development of innovative solutions to complex technical problems.

• Skilled in application of standardized root cause analysis, investigation tools and methodologies.

• Has considerable knowledge in professional field of specialization.

• Proficient with the use of MS Office software.

Education & Experience:

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

• Bachelor's degree with a minimum of 10 years of experience, preferably in virology or biochemistry

• Master's degree with a minimum of 8 years of experience, preferably in virology or biochemistry

• Ph.D. with at least 6 years of experience, preferably in virology or biochemistry

• Experience in cell culture techniques and viral assays is preferable as is experience with process scale down and chromatography.

• Knowledge and familiarity with GLP regulations or experience within a GLP environment would be a plus.

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.

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

Req ID: 515823

Type: Regular Full-Time

Job Category: Research & Development