Grifols Shared Services North America, Inc Senior Process Development Scientist I in Durham, North Carolina
Position will be hired in RTP
Provide technical or scientific expertise and leadership to the development, scale-up, transfer, and support of production processes for plasma derived or recombinant proteins.
Activities are centered on unit operations such as cell culture, fermentation, filtration, precipitation, phase separation, chromatography, formulation development and process trouble shooting.
Responsible for independently identifying action plans to support process development and process transfer.
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 facilities in accordance with procedure.
Provides and/or supervises support for developmental studies or clinical manufacturing as needed. Educational Requirements: Bachelor’s Degrees in Biology, Physics, Chemistry, Biochemistry, or Engineering and at least six years of applicable protein purification experience.orMaster’s degree in Biology, Physics, Chemistry, Biochemistry, or Engineering and at least four years of applicable protein purification experience.orDoctorate degree in Biology, Physics, Chemistry, Biochemistry, or Engineering and at least 2 years of applicable protein purification experience. Position Requirements:
Leadership experience gained through previous scientific process development roles.
Proven expertise in the scientific process development of key unit operation step(s) such as fractionation, chromatography, filtration or formulation development.
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 principles 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, formulation development, process analysis) and expanding knowledge base in professional area.
Must be proficient in use of MS Office Suite Preferred Qualifications :
Expertise in the execution of bench-scale process unit operations: chromatography, UF/DF, precipitation, depth filtration and nanofiltration. An in-depth understanding of the theory of these techniques is preferred.
Experience independently designing, executing, documenting and presenting results from process development studies.
Experience executing and interpreting results from protein analysis methods, including SDS-PAGE, SE-HPLC, spectroscopy and DLS.
Familiarity with JMP software and its use in designing and analyzing results from DOE (design of experiments) approaches to process development.
Experience maintaining laboratory facilities in accordance with procedure.
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.
Req ID: 211614