QC Functional Lead - Biologics Training Program

WuXi Biologics; Cranbury Township (NJ); On-site; USD 60,000 - 105,000; Full time

Job summary

WuXi Biologics in Cranbury NJ is seeking a Scientist I/II to lead QC functional activities within biologics programs. You will coordinate analytical strategy, testing, timelines, and deliverables with cross-functional teams.

The role emphasizes cGMP compliance, data integrity, and collaboration with client teams, with training through a structured program to develop ownership of QC projects.

Qualifications

• Strong scientific reasoning and problem-solving abilities.
• Ability to interpret analytical data and relate results to product quality.

Responsibilities

• Complete the training curriculum and maintain status for procedures and systems.
• Serve as QC functional lead for assigned biologics projects and coordinate deliverables.
• Lead cross-functional teams to implement method-transfer and analytical lifecycle strategies.
• Prepare sampling plans, release and stability protocols, and regulatory-ready data packages.
• Manage in-process, release and stability testing, and coordinate external labs as needed.
• Lead investigations (OOS/OOT), support root-cause analysis and CAPA, and ensure regulatory compliance.
• Communicate with clients and internal teams; support audits and inspection readiness.

Skills

Scientific reasoning

Problem solving

Documentation

Education

M.S./ Ph.D. in Biology or related field

Job description

WuXi Biologics in Cranbury NJ is seeking a Scientist I/II to lead QC functional activities within biologics programs. You will coordinate analytical strategy, testing, timelines, and deliverables with cross-functional teams.

The role emphasizes cGMP compliance, data integrity, and collaboration with client teams, with training through a structured program to develop ownership of QC projects.