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.
Job Summary:
Responsible for ensuring that all required product tests are validated in a timely and GMP-compliant manner.
Essential Job Duties:
Develops new biochemical and microbiological methods for testing Grifols products and process samples. Designs protocols for validating existing and new test methods and supervises execution of these protocols. Assists in the transfer of validated methods to the Grifols QC laboratory. Assists in developing and maintaining a schedule for the validation of QC tests for process intermediates and final product. Designs protocols for installation, operation and performance qualifications of new QC analytical instruments and maintains the schedule for completing these qualifications. Identifies resources, equipment and supplies that are required to perform validation of process intermediate and final product tests. Maintains system for timely purchase and qualification of laboratory equipment and reagents. Reviews and revises standard operating procedures for technical accuracy and compliance with regulatory requirements. Assists the QC department in troubleshooting or investigating instrument and assay problems. Notifies QC management of any potential quality issues related to test validations and provide recommendations for quality improvement. Maintain current knowledge of regulatory and industry standards. Generate thorough written reports, when required, that summarize investigations performed for out-of-specification results or out-of-procedure events. Participate in regulatory and internal inspections/audits including providing written responses as applicable for area of responsibility. Strict adherence to procedures and practices according to FDA regulations. Strong emphasis on documentation according to FDA regulations. Adhere to departmental corporate safety policies.
Knowledge, Skills, and Abilities Include:
Strong communication, interpersonal, organizational, and decision‑making skills. Excellent technical writing skills. Related experience in laboratory methods validation and familiarity with ICH and U.S. / European pharmacopeia guidelines for analytical methods validation is strongly preferred. Fundamental understanding of protein biochemistry, immunochemistry, microbiological testing (bioburden, endotoxin, sterility, microbial identification), and analytical techniques such as chromatography, electrophoresis, spectroscopy, and ELISA. Familiarity with statistical methods for data analysis. Ability to work independently with minimal supervision. Strong analytical and problem‑solving skills with the ability to make structured, routine decisions. Proactive, results‑oriented mindset with strong attention to detail. Self‑starter with a strong work ethic and sound judgment. Ability to effectively prioritize and manage multiple tasks to meet deadlines. Strong interpersonal skills with the ability to collaborate across all levels in a team environment. Excellent verbal and written communication skills in English. Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint). Experience with LIMS is preferred.
Job Requirements:
Education: M.S or Ph.D (Preferred) in Biochemistry, Physics, Microbiology or Life Sciences field. In lieu of a Ph.D., candidate must have a Master's degree and a minimum of 5 years’ experience working in a laboratory, at least two of which should be in the pharmaceutical, cGMP, or FDA regulated environment. 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 experience, or a Master’s degree with 2 years of experience.
*This job description is accurate at the date of publication. It is intended to provide information essential to understanding the scope and general nature of the work performed by job holders within this position. This job description is not intended to be an exhaustive list of qualifications, skills, duties, responsibilities or working conditions associated with the position. Other duties may be assigned and qualifications required may change over time.
Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.
The estimated pay scale for the Principal Scientist role based in Los Angeles, CA, is $99,480 to 110,000 annual salary. Additionally, the position is eligible to participate in up to 8% 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!
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:US403 - LA CA-QC Building
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