Microbiology Principal Scientist

GRIFOLS, S.A.

3d•$99,480 - $110,000•Onsite

About The Position

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.

Requirements

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.
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.

Nice To Haves

Experience with LIMS is preferred.

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.