Sr. Associate Stability Research Scientist II

GRIFOLS, S.A.

3d•$98,151 - $122,688•Onsite

About The Position

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.

Requirements

Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology)
MS with minimum of 3 years of relevant experience, BS with 5-6 years of relevant experience, or no degree with 9 years of relative experience.
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.
Must have good written and oral communication skills.
Applies scientific principles in problem solving.
Demonstrates knowledge in area of specialization
Takes initiative in keeping current in area of specialization.
Proficient with the use of MS Office software, DCM and SAP.
Have an understanding of the International Conference of Harmonization (ICH) guidelines and requirements set forth by regulatory agencies associated with the storage of Stability product is required.

Nice To Haves

Capable of supervising a small team of technicians.
Assist with oversight of stability chamber alarm notifications (24/7). Responsible for ensuring the implementation of a plan of action in the absence of supervisor and provide notification to Stability management.

Responsibilities

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.
Maintains stability chamber area facilities in accordance with company policies and industrial best practices.
Provides support for research and developmental studies, clinical or commercial manufacturing as needed.
Reviews and approves weight measurement testing and other designated documentation in absence of the supervisor.