Sr. Associate Stability Research Scientist I

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.

Summary:

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.  May have supervisory responsibility for up to approximately 2 scientists or technicians. The incumbent successfully performs in their position supporting a compliant stability program for 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.

 

Primary Responsibilities:

• Assists in development of actions plans in support of departmental goals.
• Provides technical reports to immediate supervisor and within group meetings.
• Independently prepares procedures or technical reports.
• With supervision, effectively communicates technical results in team settings.
• In consultation with supervisor, applies sound scientific principles in development of solutions to 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 experiments independently.
• Supports the Stability Group by overseeing all facets of the Stability Program that are related to the chamber area and has expertise in all chamber related functions.
• Reviews and approves VIT and Visual Testing in absence of the supervisor.
• Leads failure investigations for chamber related issues and authors detailed investigation reports.
• Oversees timely updates of sample handling SOPs and other GMP Stability documents.
• Participates in routine and directed internal and external audits and regulatory inspections and follow-up on any observations.
• Provide support for Grifols products (marketed and/or development)                                                                  
• Provide stability support for the research and development of plasma derived proteins
• Knowledge in the use of SAP program                                                            
• Position requires organizational and experimental design skills
• Knowledge of the Regulatory guidelines, licensed product lines, routine test methods, and developmental projects related to stability studies   
• Demonstrated ability in technical report writing and attention to detail                                                            
• Knowledge in usage of an electronic based Document Control Management (DCM) system 
• Communicates effectively and promptly supporting department objectives and management decisions        

 

Additional Responsibilities:

• Maintains laboratory facilities in accordance with company policies and industrial best practices. 
• Provides support for research and developmental studies, clinical or commercial manufacturing as needed.

 

Knowledge, Skills, & Abilities:

• Must have strong organizational skills and the ability to prioritize personal tasks to meet deadlines. Executes action plans independently or as part of a team.
• Capable of supervising a small team of technicians.
• Must have good written and oral communication skills.
• Applies scientific principles in problem solving.<