Principal Scientist - Method Development and Validation

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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.

 

Job Requirements:

 

• M.S or Ph.D (Preferred) in Biochemistry, Physics, or Life Sciences field. 
• Related experience in laboratory methods validation and familiarity with ICH and U.S. / 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 methods validation experience in a pharmaceutical, GMP, or FDA regulated environment.
• Requires a fundamental understanding of analytical methodology, protein biochemistry, immunochemistry, chromatography, electrophoresis, spectroscopy, and ELISA.
• Requires a familiarity with statistical methods for data analysis.
• Must have strong technical writing skills.
• Ability to work independently with minimum supervision.
• Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
• Must be proactive, results oriented, and have strong attention to detail.
• Self-starter with strong work ethic and the ability to exercise good judgment.
• Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines.
• Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
• Excellent verbal and written communication skills in the English language.
• Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
• Specific experience with LIMS is preferred.

 

The estimated pay scale for the Principal Scientist - Method Development and Validation role based in Los Angeles, CA, is $95k -$110k per year. 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 co