Principal Scientist, QC Analytical

Job Description

Job Description

Description:

The Principal Scientist, QC Analytical serves as a senior scientific expert within the Quality Control organization, providing advanced technical leadership, method development oversight, and subject-matter expertise for analytical activities supporting raw materials, intermediates, drug substances, and final products. This role drives the development, qualification, and validation of complex analytical methods, supports technology transfer activities, and ensures analytical programs meet regulatory, corporate, and scientific standards. The Principal Scientist leads high-level investigations, provides technical mentorship across departments, and contributes to strategic initiatives supporting continuous improvement of QC Analytical operations.

Requirements:

• Provide expert leadership in analytical testing for biologics, vaccines, cell/gene therapies, or APIs, including techniques such as HPLC/UPLC, GC, CE, ELISA, compendial methods, spectroscopy, and bioassays.
• Provide expert guidance for method lifecycle management, including phase-appropriate validation strategies and regulatory expectations.
• Lead technical transfer of analytical methods from Process Development, Protein Characterization, and external partners into QC, ensuring successful integration into routine testing operations.
• Act as primary scientific reviewer of QC analytical data, reports, protocols, and investigations to ensure accuracy, compliance, and scientific integrity.
• Support the design, review, and execution of stability studies; develop stability-indicating methods and oversee evaluation of long-term and accelerated data.
• Serve as the QC Analytical SME during audits, regulatory inspections, client meetings, and cross-functional technical discussions.
• Provide advanced technical support for atypical results, including OOS, OOT, and ABT investigations; lead root cause analysis and propose scientifically sound corrective and preventive actions.
• Contribute to continuous improvement initiatives, including new technologies, workflow optimization, data integrity enhancements, and analytical efficiency improvements.
• Collaborate with QA, Manufacturing, Process Development, and Protein Characterization groups to resolve complex analytical issues and ensure alignment across teams.
• Prepare and review scientific documentation including method development reports, validation protocols, stability reports, and analytical risk assessments.
• Mentor and guide QC Analysts and Scientists, providing training in new methods, instrumentation, regulatory expectations, and scientific best practices.
• Maintain deep knowledge of compendial, ICH, and FDA guidance and ensure analytical strategies align with current regulatory expectations.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Education and Skills Required:

• Ph.D. in biological sciences, biochemical sciences, analytical chemistry, or related field preferred or Master’s degree with extensive relevant experience may be considered.
• Minimum of 8–10 years of experience in a GMP, FDA-regulated environment with a strong focus on analytical development, validation, and QC laboratory operations
• Proven track record of leading analytical teams and complex technical projects
• Expert-level knowledge of analytical methodologies such as HPLC/UPLC, CE, MS, ELISA, qPCR, and other characterization techniques.
• Strong organizational, documentation, and time-management capabilities with high attention to detail.