Sr. Associate Stability Research Scientist II

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.

The incumbent will provide technical and scientific expertise in the research and development of plasma derived or recombinant proteins or in support of the manufacture of plasma derived or recombinant proteins. The incumbent is a technically competent professional who uses their expertise to assist in executing a compliant stability program to support licensed products and developmental projects, ensuring the on-going quality and safety of marketed material, in addition to implementing solutions to a variety of company related objectives.

 

The incumbent will be responsible for providing stability support for Grifols products (marketed and/or development) by generating stability protocols and reports, reviewing and analyzing incoming data, authoring Stability documents in support of Regulatory submissions, assisting with the initiation of stability studies and sample pulls, and assisting with maintaining the Stability chamber area in a compliant state. He/she may participate in interdepartmental product project teams and present stability data to peer and management groups. In addition, he/she will work in partnership with Quality/Manufacturing/Technical Operations/Supply Chain/Research and Development to conduct and resolve investigations of unexpected stability data and trends. Additional responsibilities may be assigned by department manager.

Responsibilities for Sr Associate Stability Research Scientist II

• Provide support for Grifols products (marketed and/or development).
• Provide stability support for the research and development of plasma derived proteins.
• Assist in the development of action plans in support of departmental goals.
• Executes action plans independently or as part of a team. Capable of reporting project activities to immediate supervisor and within group meetings.
• Provides technical reports to immediate supervisor and within group meetings.
• Independently prepares technical reports, including data interpretation.
• With minimal supervision, prepares and effectively communicates technical results in cross-functional team settings.
• In consultation with supervisor, independently applies sound scientific principles in development of solutions to complex technical problems within area of expertise.
• Applies professional principles, established techniques, and company's policies and procedures in completion of job tasks.
• Assists in the design and interpretation of results for scientifically complex experiments.
• Executes stability studies. Collects, reviews, analyze and interpret stability data.
• Assists with failure investigations for chamber related issues and may author detailed investigation reports for the failure.
• Author stability reports/documents to support the annual product reviews and regulatory submissions under direction of supervisor.
• Oversees timely updates of Stability SOPs and independently revise them along with other GMP Stability documents.
• Participates in all internal and external audits and regulatory inspections and follow-up on any observations.
• Position requires great organizational and experimental design skills and acute attention to detail.
• Knowledge of the Regulatory guidelines, licensed product lines, routine test methods, and developmental projects related to stability studies.
• Demonstrated ability in technical report writing.
• Usage of site systems (such as Document Control Management (DCM) system and SAP) to perform job responsibility related activities.
• Communicates effectively and promptly supporting department objectives and management decisions.

Additional Responsibilities:

• Maintains stability chamber area facilities in accordance with company policies and industrial best practices.
• Provides support for re