Grifols Shared Services North America, Inc Principal Scientist - QC Methods Development & Validation in Los Angeles, California

Grifols is a global healthcare company whose mission is to improve the health and well-being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.

We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.

Position Summary:

  • Responsible for ensuring that all required product tests are validated in a timely and GMP-compliant manner.

Job Responsibilities: (This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.)

  • 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.

  • Provides information for internal and external audits on the GMP validation status of QC equipment, reagents and tests. Assists in the resolution of audit observations related to validations and proposes corrective actions.

  • Notifies QC management of any potential quality issues related to test validations and provide recommendations for quality improvement.

Skills/Experience, Qualifications, and Educational Requirements: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).

  • Ph.D. in Chemistry, Biochemistry, Physics or related Life Sciences field or closely related scientific/ technical discipline is required. Experience in laboratory method validation and familiarity with ICH and U.S. and European pharmacopeia guidelines for analytical methods validation is strongly preferred.

  • Equivalency: In lieu of a Ph.D., candidate must have a Master's degree and a minimum of 5 years of related experience in a pharmaceutical, GMP, or FDA regulated environment. Experience in laboratory method validation and familiarity with ICH and U.S. and European pharmacopeia guidelines for analytical methods validation is strongly preferred.

  • Requires a fundamental understanding of analytical methodology, protein biochemistry, immunochemistry, chromatography, electrophoresis, spectroscopy, and ELISA.

  • Requires a familiarity with statistical methods for data analysis.

  • Strong communication, interpersonal, organizational and decision making skills.

  • Strong technical writing skills.

  • Requires a fundamental understanding of analytical methodology, protein biochemistry, immunochemistry, chromatography, electrophoresis, spectroscopy, and ELISA.

  • Requires a familiarity with statistical methods for data analysis.

*This job description is accurate at the date of publication and may change over time. It is not intended as an exhaustive description of the job. Other duties may be assigned and qualifications required may change.

EEO Minorities/Females/Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Location: [[mfield6]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home