Job Description

PRINCIPAL SCIENTIST - QC

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

Develops new biochemical and microbiological methods for testing 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 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.

Requirements:

• Ph.D. in Chemistry, Biochemistry, Physics or related Life Sciences field or closely related scientific/ technical discipline is required.

• 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.

To apply for this position, send a copy of your resume in word or pdf format to info@branfordsearch.com