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 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. 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, DCM and SAP. 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. 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. 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. 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.
The estimated starting pay scale for the Sr. Associate Stability Research Scientist II based in Los Angeles, CA, is as follows: $98,151- 122,688. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
Occupational Demands:
Work is performed in an office and/or a stability chamber/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. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Moderate lifting of 15-30Ibs. 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; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws, including but not limited to, the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
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Location: NORTH AMERICA : USA : CA-Los Angeles:USVALLEY - Valley Bl Mfg Plant - LA, CA
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