Associate Scientist, QC Analyst Training Program

About the role

The QC Functional Lead Training Program develops scientifically strong M.S. and Ph.D. candidates into Quality Control functional leads who can coordinate analytical strategy, testing execution, timelines, documentation, and client deliverables across biologics programs. The program supports both recent graduates and experienced hires through an initial competency assessment and a role-specific development plan. The Scientist II serves as the QC functional lead for assigned projects and works closely with QC testing functions, Analytical Development, Process Development, MSAT, Manufacturing, Quality Assurance, Project Management, CMC leaders, and client teams. The role supports method transfer and qualification strategy, in-process, release, and stability testing, investigations, documentation, and delivery of complete QC data packages in accordance with approved procedures and cGMP requirements.

Training Program Structure: Training is organized into required and assignment-specific modules. Each module combines scientific theory, data or case-based instruction, supervised practice, and mentored application to active or simulated QC projects. Required scientific and QC foundation: All participants complete training in biotechnology and protein therapeutics, critical quality attributes, analytical control strategy, product lifecycle, and the purpose of in-process, release, stability, characterization, and comparability testing. Required compliance and documentation foundation: All participants complete cGMP, Good Documentation Practices, ALCOA+ data integrity, laboratory safety, controlled records, investigation fundamentals, and applicable regulatory and compendial training. Assignment-specific technical modules: PCT, BIT, separation-assay, bioassay, impurity-testing, method-transfer, qualification, and other special-topic modules are assigned according to the candidate’s project scope and technical responsibilities at hiring. Functional lead practice and qualification: Recent graduates complete the full curriculum and progress from shadowing to ownership of defined deliverables. Experienced hires complete a structured gap assessment and accelerated training where appropriate. All participants must demonstrate readiness through reviewed work products and a mentored QC project before independent assignment.

Responsibilities

• Complete the assigned training curriculum, technical modules, supervised activities, and functional lead qualification; maintain current training status for applicable procedures and systems.
• Serve as the QC functional lead for assigned biologics projects and coordinate integrated or standalone QC deliverables, priorities, timelines, risks, and communications.
• Lead matrix teams across Analytical Development and QC testing functions to establish and execute method-transfer, qualification, and analytical lifecycle strategies.
• Prepare or coordinate sampling plans, specifications, release and stability protocols, technical summaries, certificates, and other project documentation in a timely and compliant manner.
• Manage in-process, release, stability, and assigned cell-bank testing; coordinate external laboratory selection, sample shipment, oversight, and result integration when