Sr. Associate Stability Research Scientist I
Grifols Shared Services North America, Inc
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.
+ Demonstrates knowledge in area of specialization
+ Takes initiative in keeping current in area of specialization.
+ Proficient with the use of MS Office software. Primary responsibility for oversight of chamber alarm notifications (24/7). Responsible for ensuring the implementation of a plan of action and notification of management. An understanding of International Conference of Harmonization (ICH) guidelines and requirements set forth by regulatory agencies associated with the storage of Stability product is required.
**Requirements:**
+ Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology)
+ MS + 1 yrs OR BS + 3-4 yrs OR No degree + 7
_Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience._
**Occupational Demands:**
Work is performed in a clinical and/or a laboratory environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Exposure to chemicals. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits and bends neck for 4-6 hours per day. May stand and twist neck for 2-4 hours per day. Occasionally walks, bends and twists waist and squats. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30lbs. with a maximum lift of 35 lbs. May reach above and below shoulder height. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently works with diverse groups to obtain consensus on complex issues. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.**
Learn more about Grifols (https://www.grifols.com/en/what-we-do)
**Req ID:** 523256
**Type:** Regular Full-Time
**Job Category:** Research & Development
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