Specialist I, AS&T

Role: Support analytical sciences and technology activities within a biopharma setting, ensuring compliant laboratory systems and methods throughout their lifecycle. Responsibilities include transferring, verifying, and validating analytical methods; supporting instrument qualification and laboratory system implementation; authoring SOPs, protocols, and reports; and maintaining data integrity. Additionally, support laboratory investigations, deviations, CAPAs, and cross-functional collaborations with QC, Manufacturing Tech, and other teams. Requirements: Bachelor's in Chemistry, Biochemistry, Biology, or related field; at least 5 years' relevant experience; proficiency with immunological, bioanalytical, and chemical test methods (e.g., ELISA, qPCR, HPLC, microbiological methods); knowledge of cGMP, 21 CFR Part 11, data integrity, and analytical validation; ability to apply statistical analysis. Preferred: experience with GMP-compliant analytical method validation and vaccine or biotherapeutic products. HighValue: laboratory systems support, analytical method lifecycle management, GMP compliance, regulated quality systems, cGMP/GLP, and laboratory instrumentation. Cross-functional interaction with QC, Manufacturing Tech, and Quality Assurance teams. WorkSetup: not specified; physical/mental demands and accommodations provided.