Associate Specialist/Specialist, Site Analytical Sciences (SAS)

Purpose

The Site Analytical Sciences Associate Specialist/Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations and biochemistry.

Key Responsibilities

• Support/Lead analytical method transfers, validations, and compendial method verifications.
• Perform laboratory-based analytical testing and technical studies using a variety of analytical techniques and instrumentation.
• Generate, review, interpret, and verify analytical data and technical documentation.
• Support lifecycle management and continuous improvement of analytical methods.
• Assist with troubleshooting of analytical methods and laboratory equipment.
• Support equipment performance qualification activities (PQ).
• Participate in laboratory investigations, deviations, CAPAs, and change controls.
• Collaborate with Quality Control, Manufacturing, Validation, Technical Operations, and Global Analytical teams.
• Ensure compliance with cGMP, data integrity, safety, and regulatory requirements.
• Supporting digital method development.

Qualifications & Experience

Education

• Bachelor's Degree in Analytical Chemistry, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related scientific discipline.

Experience

• Minimum 2-3 years' experience within the pharmaceutical, biotechnology, or vaccine industry.
• Experience working in a GMP-regulated laboratory environment.
• Experience with analytical testing, data review, and technical documentation.
• Experience with method validation, method transfer, compendial testing, chromatography, electrophoresis, ELISA or analytical troubleshooting is advantageous.

Desired Technical Skills

• HPLC/UHPLC (Agilent/ Waters)
• CE-SDS (AB Sciex instruments)
• icIEF (Maurice, Biotechne)
• Empower Software Competency
• Solo VPE
• ELISA
• Cell Based Assay
• Compendial testing and Method Verifications
• Data analysis and technical report writing
• Laboratory investigations and root cause analysis
• GMP documentation and data integrity practices