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Grifols Shared Services North America, Inc Senior Process Development Engineer/Scientist I in Clayton, North Carolina

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Summary:

The incumbent will provide technical or scientific expertise and leadership to the development, scale-up, clinical manufacture, transfer, and/or support of production processes for plasma derived proteins. Technical competencies are centered on unit operations such as filtration, precipitation, phase separation, chromatography, lyophilization, and fill-finish operations. Effective project management, collaboration, critical thinking, problem solving, and technical writing skills are essential. Participation on cross-functional teams and supervisory responsibility for up to approximately 4 scientists, engineers, or technicians are anticipated.

Primary Responsibilities for role:

  • Independently identify action plans to support departmental objectives.

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

  • Represent the functional area or lead cross-functional teams to achieve identified objectives.

  • Independently prepare and critically edit procedures or technical reports of a complex nature, assimilating information across functional areas, suitable for inclusion a regulatory submission.

  • Communicate functional area and departmental results in cross-functional settings.

  • Develop creative novel process development solutions or technical implementation plans to meet departmental objectives.

  • Develop innovative solutions to complex technical problems and leads other in problem solving efforts

  • Independently design, execute, and interpret results for novel and scientifically rigorous study programs and mentor others in experimental design. May direct others in study execution.

  • Support start-up and commissioning of equipment and processes.

  • During technical transfer, provide technical review of design documents for assigned systems.

  • Ensure scalability of unit operations during process development and can anticipate equipment related scaling issues and develop sound engineering solutions.

  • Lead drug substance group responsible for supporting process development and manufacturing in plasma fractionation and purification activities.

Additional Responsibilities

  • Provide and/or supervise support for developmental studies, clinical or commercial manufacturing as needed.

  • Identify, implement, and qualify, as necessary, existing or novel technologies to achieve operational needs in compliance with regulatory expectations.

  • Maintain laboratory and/or clinical manufacturing facilities in accordance with procedure.

Knowledge Skills and Abilities:

  • Project management experience with strong ability to set and meet deadlines, multitask, as well as identify, request, and prioritize resources based on project needs.

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

  • Advanced written and oral communication skills.

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

  • Extensive knowledge in professional field of specialization (e.g., purification, formulation, process analysis) and can mentor/train junior staff in relevant principles.

  • Knowledge of cGMP and application to clinical manufacturing.

  • Demonstrated leadership skills and ability to drive results.

  • Ability to effectively collaborate and build alignment to achieve departmental objectives

Preferred Qualifications:

  • Knowledge of cGMP and application to clinical manufacturing.

  • Experience in process development at bench and pilot scale.

  • Knowledge of the principles of scale-up and scale-down for key unit operations associated with processing of biologicals.

  • Experience in technical writing.

  • Experience in identifying project risks.

Education:

Chemical, Biochemical, or relevant field in engineering or science.

Experience:

BS + 8 yrs. experience, MS + 6 yrs., PhD. + 2 yrs.

EEO: Minorities, Women, Disabled, Veterans

Req ID: 251667

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