CA Los Angeles Senior Stability Research Scientist II CA 90001

Job description

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. Description: The incumbent will work in a supporting function to provide scientific and technical assistance in the research and development of plasma derived or recombinant proteins. The position provides support to the Stability Group by overseeing all facets of the stability program that are related to oversight of stability related investigations, the stability chamber areas, storage, delivery and documentation of the sample inventory in order to maintain a compliant stability program for licensed products and developmental projects, ensuring continued safety and quality of our products. The incumbent will provide technical or scientific expertise and leadership in the research development of plasma derived or recombinant proteins or in support of the manufacture of plasma derived or recombinant proteins. May lead cross functional teams or represent functional area on cross functional teams. The incumbent is a technically competent professional who assists in leading a compliant Stability program to support licensed products and developmental projects, ensuring the continued quality and safety of marketed material, in addition to implementing solutions to a variety of company related objectives. Responsibilities of this position include but are not limited to: Responsible for independently identifying actions required to support departmental objectives and capable of making decisions within designated assignments that influence the goals of the department Executes action plans independently, as part of a team, or as the lead for a departmental team Responsible for representing the functional area or capable of leading a cross-functional team to achieve identified objectives Independently prepares and critically edits procedures or technical reports of a complex nature, assimilating information across functional areas, suitable for inclusion in IND or BLA Develops creative, novel programs to meet departmental objectives. Leads others in problem-solving efforts Advanced ability to creatively apply scientific principles in problem solving in potentially novel area Mentors/trains staff in relevant principles and/or guidelines Responsible for serving as technical consultant within functional area or site Independently designs, executes, and interprets results for novel and scientifically complex study programs Mentors others in experimental design Responsible for directing others in study execution Knowledge in usage of site systems applicable to stability studies (such as DCM, SAP and Apogee) Develops alternative solutions to problems, handles complex problems independently Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions Collects, reviews, and analyzes Stability data Generates, reviews and approves stability documentation in accordance with project and site requirements Authors and/or reviews stability reports/documents to support the annual product reviews and regulatory submissions Executes assignments of high complexity for the business unit Provides departmental training 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 and serve as subject matter expert for the Stability program Demonstrated ability in technical report writing and attention to detail Knowledge in usage of an electronic based Document Control Management (DCM) system Additional Responsibilities: Maintains work areas in accordance with company policies and industrial best practices Provides support for research and developmental stability studies, and clinical or commercial manufacturing, as needed Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations Previous experience in creating and delivering presentations to a wide variety of audiences Execute assignments of high complexity for the business unit Ability to lead projects for the business unit Provides training for new employees Acts as subject matter expert for audits/inspections during the absence of the department Manager Educational Requirements, Knowledge, Skills and Abilities beneficial to position (but are not limited to): Education: Completed PhD + 0-2 years of experience, MS + 8 years of experience, or BS + 10-11 years of experience. Educational degrees must be relevant to position (e.g., Biology, Biochemistry, Chemistry, or Toxicology). 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. Strong ability to set and meet deadlines, multitask, as well as identify, request, and prioritize resources based on project needs Demonstrates strong critical judgment and strategic thinking skills in representation of functional area concerns on cross functional teams Capable of representing the functional area on a cross-functional team and presenting technical data at team meetings Can identify and request needed resources within or across functional areas Capable of supervising up to eight scientific personnel Effectively communicates functional area and departmental results in cross-functional settings Must have advanced written and oral communication skills Independently applies sound scientific principles in development of innovative solutions to complex technical problems Skilled in application of standardized root cause analysis, investigation tools and methodologies Statistical data analysis (including use of SAS JMP or equivalent statistical software) Has considerable knowledge in professional field of specialization Proficient with the use of MS Office software Fully qualified professional who requires minimal supervision Demonstrated ability in technical report writing and attention to detail Technical knowledge sufficient to conduct and resolve stability investigations is expected Knowledge of cGMP practices Sample management experience Experience with monitoring and upkeep of validated temperature-controlled units FDA and ICH guidelines concerning stability studies An understanding of ICH guidelines and GMP requirements set forth by regulatory agencies associated with the storage of Stability product is required. Good communication skills are needed to generate effective written and oral reports that are clear, accurate, and logical. The incumbent must possess excellent interpersonal and communication skills to interact effectively and promptly with all levels of the organization, supporting departmental objectives and management decisions, and maintaining good working relations with multiple cross-functional teams. The incumbent must possess a working knowledge of equipment and storage facility operations and be able to quickly resolve problems associated with chamber related issues. The incumbent must possess excellent skills regarding determination of the impact of a deviation upon the stability program and be able to ensure corrective actions for each discrepancy have been implemented and are effective to prevent reoccurrence. The incumbent must possess computer skills regarding working use of w