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Grifols Shared Services North America, Inc Principal Process Development Scientist I in Durham, North Carolina

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

The incumbent will be primarily responsible for identifying conditions that stabilize proteins through manufacturing processes and remain stable during transportation, storage and administration. The incumbent may be responsible for major projects of a technically complicated nature.

Primary Responsibilities:

  • Responsible for developing functional area objectives in support of departmental objectives/corporate goals and evaluating project risks.

  • Independently writes technical reports of a complex nature suitable for inclusion in IND, BLA, or external publication.

  • Develops creative novel protein formulation solutions to meet corporate objectives and open new business opportunities.

  • Develops resource plans to achieve identified objectives/goals.

  • Communicates technical and project results and critical information to technical and/or non-technical audiences.

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

  • Independently designs, executes, and interprets results for novel and scientifically rigorous study programs that may be highly complex in nature.

  • May conduct laboratory studies using standard processing and analytical equipment.

  • Uses software such as JMP for Design of Experiments and statistical analysis

Position Requirements and Qualifications:

  • Fundamental knowledge of protein chemistry and analysis of proteins

  • Possesses ability to identify and implement existing or novel formulations into manufacturing processes in a regulated environment

  • Advanced ability to set and meet deadlines based on project needs.

  • Demonstrates advanced critical judgment and strategic thinking in representing functional area concerns on cross functional teams.

  • Must demonstrate advanced ability to produce, oversee, and/or deliver written and oral presentations for technical and leadership audiences.

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

  • Maintains advanced knowledge, is recognized and consulted as an expert in professional field (e.g., formulation, purification, cell culture, process analysis) within functional area.

Preferred Qualifications:

  • Drug product formulation specialist with experience developing intermediate and final formulations of protein therapeutics, including liquid and lyophilized drug product in appropriate container closures

  • May have experience with high concentration protein formulations

  • Understands protein stability and methods to assess stability

  • Previous experience working within and/or leading cross-functional, interdepartmental projects

  • Previous experience in bench-scale/pilot-scale process and product development studies

  • Experienced in drafting, reading, and revising technical reports

  • Previous experience authoring and/or reviewing regulatory submission documents

Minimum Education and Experience:

Bachelor's degree in a relevant science (e.g., Biology, Biochemistry, Chemistry, Biophysics) or engineering field (e.g., Chemical, Biochemical, Biomedical) with 10+ years of relevant experience or an equivalent combination of post graduate education and years of experience.

EEO Minorities/Women/Disabled/Veterans

Req ID: 283330

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