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:

As a key member of the team, the incumbent will provide comprehensive technical and scientific expertise and leadership in the development, scale-up, transfer, and support of production processes for plasma-derived proteins. The role focuses on advanced purification unit operations, including but not limited to precipitation, filtration, chromatography, tangential flow filtration, formulation, nanofiltration, and process troubleshooting. The successful candidate will leverage their scientific knowledge and hands-on experience to contribute to the advancement of innovative therapies.

Primary Responsibilities :

• Supports and/or directs developmental projects, manufacturing support projects, clinical manufacturing, and commercial manufacturing.

• Independently and/or collaboratively Identifies action plans to support departmental objectives

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

• Independently and/or collaboratively prepares and edits procedures or technical reports of varying complexity, including data interpretation, which may be suitable for inclusion in IND, BLA, or equivalent regulatory submission.

• Prepares and reports technical results in internal and cross-functional team settings.

• Develops innovative solutions to complex technical problems and may leads others in problem solving efforts.

• Independently or collaboratively designs, executes, and interprets results for novel and/or scientifically rigorous experiments. May direct others in study execution.

• Ability to execute experiments independently and to direct others and lead study execution.

• Conducts laboratory and clinical production work using standard processing and analytical equipment.

• Identifies, collects, and analyzes data on critical process attributes and/or critical parameters for scaling.

• Supports the execution of start-up and commissioning for equipment and processes as well as implementation of new raw materials on-site.

• Maintains laboratory and clinical manufacturing facilities in accordance with procedures.

Knowledge Skills and Abilities :

• Possesses a strong ability to set and meet deadlines, multi-task, and prioritize personal objectives and other resources based on project needs.

• Exhibits the ability to adapt to a changing work environment.

• Must have experience in technical writing, which may include laboratory notebook maintenance

• Must have advanced written communication and excellent oral communication skills.

• Strong ability to creatively apply scientific or engineering principles in problem solving.

• Must have experience working at various process scales ranging from bench to pilot scale.

• Has knowledge and experience working in a GMP environment.

• Demonstrates critical judgment and strategic thinking sufficient to represent functional area concerns on cross-functional teams.

• Has considerable/extensive knowledge in professional field of specialization (e.g., purification, formulation, process analysis, etc) and may be able to mentor/train junior staff in relevant principles and/or guidelines.

• Must be self-motivated and able to work effectively in a matrixed organization.

• Must be proficient in use of MS Office Suite.

Location: Clayton, NC

Shift: Day

Education and Experience Requirements :

Process Development Engineer:

Bachelor’s degree in a relevant science or engineering field with 7+ years of relevant work experience OR Associates Degree with 9+ years of experience OR an equivalent combination of education and experience.

Senior Process Development Engineer I:

Bachelor’s degree in a relevant science or engineering field with 8+ years of relevant work experience OR Associates Degree with 10+ years of experience OR an equivalent combination of education and 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, 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: 525719

Type: Regular Full-Time

Job Category: Research & Development