QC Scientist I: Method Transfer & Validation

WuXi Biologics; Cranbury Township (NJ); On-site; USD 70,000 - 95,000; Full time

Job summary

WuXi Biologics seeks a Scientist I, QC, at our Cranbury, NJ site to drive method transfer and validation documentation while conducting assays per cGMP standards. This role collaborates with internal teams and clients to ensure timely project delivery and regulatory compliance.

The successful candidate will perform protein analyses using SEC-HPLC, peptide mapping, iCIEF, and related techniques, train others, and lead small project teams with a focus on data integrity and continuous improvement.

Qualifications

• Bachelor’s degree with 4–6 years of experience in the professional field.
• Knowledge of cGMP, ICH, EMA, FDA regulations and guidance for biologics.
• Experience in analytical development or QC operations.
• Experience with modern analytical instruments for protein analysis.
• Ability to draft protocols/reports and summarize data.
• Experience with method qualification or validation.
• Ability to lead analytical support for multiple projects.
• GDP/ALCOA+ documentation practices.

Responsibilities

• Lead method transfer, including personnel training, data review, and documentation completion.
• Conduct assays and lab procedures per cGMP and SOPs (e.g., Protein Concentration by A280, SEC-HPLC, peptide mapping, N-glycan, CE-SDS NR/R, iCIEF).
• Ensure analytical data accuracy, precision, and robustness per methods and specs.
• Maintain training, testing, and lab maintenance per industry standards.
• Prepare validation documents for new products, process changes, and qualifications.
• Train new employees and transfer established work processes; lead 2–3 person project teams.
• As FL or co-FL, oversee project workstreams and clear division of responsibilities.

Skills

Analytical leadership

Data analysis

Training others

Project management

Documentation

Education

Bachelor’s degree in biology/chemistry/related field

Master’s degree in related field

Tools

SEC-HPLC

iCIEF

Size Exclusion Chromatography

Peptide mapping

Capillary Electrophoresis

Job description

WuXi Biologics seeks a Scientist I, QC, at our Cranbury, NJ site to drive method transfer and validation documentation while conducting assays per cGMP standards. This role collaborates with internal teams and clients to ensure timely project delivery and regulatory compliance.

The successful candidate will perform protein analyses using SEC-HPLC, peptide mapping, iCIEF, and related techniques, train others, and lead small project teams with a focus on data integrity and continuous improvement.