Grifols · 19 hours ago
Microbiology Principal Scientist
Grifols is a global healthcare company that has been working to improve health and well-being since 1909. The role of the Microbiology Principal Scientist involves developing and validating biochemical and microbiological testing methods for Grifols products, ensuring compliance with regulatory standards, and supervising the transfer of validated methods to the QC laboratory.
BiotechnologyHealth CareManufacturing
Responsibilities
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
Qualification
Required
M.S or Ph.D 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
Strong communication, interpersonal, organizational, and decision‑making skills
Excellent technical writing skills
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)
Preferred
Related experience in laboratory methods validation and familiarity with ICH and U.S. / European pharmacopeia guidelines for analytical methods validation is strongly preferred
Experience with LIMS is preferred
Education: M.S or Ph.D (Preferred) in Biochemistry, Physics, Microbiology or Life Sciences field
Benefits
Medical
Dental
Vision
PTO
Up to 5% 401(K) match
Tuition reimbursement
Company
Grifols
Grifols is a global healthcare company.
H1B Sponsorship
Grifols has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.51BKey Investors
Michael J. Fox Foundation
2025-01-14Grant· $21M
2024-06-04Post Ipo Debt· $1.41B
2024-04-23Post Ipo Debt· $1.07B
Leadership Team
Recent News
2025-12-24
Pharma Letter
2025-11-28
Company data provided by crunchbase