Job: Process Development Scientist, Grifols, Durham, NC
•Provide leadership through process development, process transfer, and technical support of production processes for plasma derived proteins.
•Responsible for independently identifying action plans to support process development, process transfer, and technical support projects.
•Execute action plans independently, as part of a team, or as the lead for a departmental or cross-functional teams.
•Independently prepare and edit procedures or technical reports of a complex nature, including data interpretation, suitable for inclusion in regulatory submissions.
•Communicate functional area and departmental results in cross-functional settings.
•Develop innovative solutions to complex technical problems and leads others in problem solving efforts.
•Independently designs, executes, and interprets results for novel and scientifically rigorous experiments. May direct others in study execution.
•Supports the execution of start-up and commissioning of equipment and processes.
•During technical transfer, provides technical review of design documents for assigned systems.
•Maintains laboratory and clinical manufacturing facilities in accordance with procedure.
•Provides and/or supervises support for developmental studies, clinical or commercial manufacturing as needed.
•Identifies, implements, and qualifies, as necessary, equipment to achieve operational needs in compliance with regulatory expectations.
Bachelor’s Degrees in Biology, Physics, Chemistry, Biochemistry, or Engineering and at least six years of applicable experience.
Master’s degree in Biology, Physics, Chemistry, Biochemistry, or Engineering and at least four years of experience.
Doctorate degree in Biology, Physics, Chemistry, Biochemistry, or Engineering and 0-2 years of experience.
•Leadership experience gained through previous scientific process development and/or process transfer role(s)
•Proven expertise in the scientific process development of key unit operation step(s) such as fractionation, chromatography, filtration, formulation, or lyophilization.
•Must demonstrate strong interpersonal skills and the ability to integrate into a cross-functional team based organization.
•Must have strong organization skills and the ability to set and meet deadlines, multitask, and prioritize personal tasks based on project needs.
•Must have excellent written communication and strong oral communication skills.
•Willingness to take initiative with multiple tasks and collaborations
•Creative and forward-thinking
•Has ability to apply scientific or engineering principles, established cGMP techniques, and company’s policies and procedures in completion of job tasks.
•Has extensive knowledge and takes initiative in keeping current in professional area of specialization(e.g., fractionation, purification, formulation, filling, lyophilization, process analysis) and expanding knowledge base in professional area.
•Must be proficient in use of MS Office Suite
Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent 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. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. 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 and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.