Sr. Scientist, Analytical R&D

Job Overview

A fantastic opportunity has arisen for an Analytical R&D (Senior Scientist) to join the Global Quality Large Molecule Analytical Sciences (GQ‑LMAS) team. GQ‑LMAS leads the global analytical technical oversight of late‑stage pipeline programs through commercialization and launch as well as product lifecycle management support for large molecules (vaccines and biologics) and cross‑modality compounds (e.g., antibody‑drug conjugates).

• Provide analytical technical oversight with external providers and internal cross‑functional stakeholders to support analytical testing of large‑molecule products.
• Maintain significant on‑site presence at external testing providers to support direct engagement and technical oversight of critical analytical activities.
• Build and maintain strong relationships with external entities and internal operations, technology, analytical, and procurement organizations.
• Collaborate with commercial manufacturing teams to support facility start‑up and sustainability activities.
• Interface with global analytical working groups and global method owners/SMEs.
• Drive continuous improvement initiatives to enhance the quality and robustness of external testing through implementation of proactive tools, assay data trending, corrective actions, and best practices.
• Identify and resolve analytical issues, deviations, and out‑of‑specification results from external labs through technical support, investigation, and troubleshooting.
• Lead or support complex investigations and drive resolution of analytical technical issues.
• Build and manage project plans, timelines, and schedules to meet project deliverables.
• Ensure external testing sites are prepared for inspections by agencies such as FDA, EMA, and PMDA from an analytical technical perspective.
• Author and/or review technical documents to support Process Performance Qualification, licensure, and regulatory technical questions.

• Bachelor's Degree with a concentration in biology, chemistry, biochemistry, or a related science and six (6) years of industry experience in analytical testing, development, transfer, and/or validation.
• Master's Degree with a concentration in biology, chemistry, biochemistry, or a related science and four (4) years of industry experience in analytical testing, development, transfer, and/or validation.
• PhD with a concentration in biology, chemistry, biochemistry, or a related science and two (2) years of industry experience in analytical testing, development, transfer, and/or validation.

• At least 4 years working in a GXP laboratory environment in the area of large‑molecule analytics (vaccines, biologics) or cross‑modality compounds.
• Experience in analytical product life‑cycle activities (development, validation, and/or transfer) across various large‑molecule platforms (e.g., ELISA, HPLC, CE).
• Understanding of biologics analytical technologies such as bioassays (ELISA, cell‑based methods), chromatography (HPLC, UPLC), and general biochemistry methods.
• Experience in the biopharmaceutical manufacturing industry, including biologics or vaccines commercialization, technical operations, and/or quality control.
• Knowledge of in‑process controls, drug substance and product release, stability, and extended characterization testing for vaccines and biologics.
• Experience with regulatory requirements and guidelines according to ICH, USP, Ph. Eur., and JP.
• Strong organizational and project‑management skills to handle multiple tasks simultaneously.
• Strong oral and written communication skills to effectively convey technical information and risks to technical and non‑technical stakeholders.

• Knowledge of deviation management and change‑control processes.
• Ability to analyze, interpret, and troubleshoot analytical data.
• Experience in method transfer, method validation, new product introduction, and/or analytical product life‑cycle activities across various large‑molecule franchises and platforms.
• Experience interfacing with external partners such as CMOs and CTLs.
• Self‑motivated with a positive, proactive, and service‑oriented mindset.
• Capabilit…