Scientist I, QC

WuXi Biologics; Cranbury Township (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

WuXi Biologics in Cranbury, NJ seeks a Scientist I in QC to support method transfer, validation documentation and execution of assays in compliance with cGMP guidelines.

The candidate will collaborate with internal teams and clients to ensure timely project deliveries, train staff, and oversee project work streams in a fast-paced biopharma environment.

Qualifications

• Bachelor's degree in biology, chemical engineering, chemistry, pharmacy or related field with relevant experience.
• Experience in analytical development or QC operations in the pharmaceutical industry.
• Knowledge of cGMP, ICH, EMA, FDA and global guidance.
• Experience with analytical instruments for protein analysis (SEC‑HPLC, iCE3, peptide mapping, etc.).
• Ability to draft and review protocol/reports and to summarize technical data.

Responsibilities

• Ensure successful method transfer including training of personnel and documentation review.
• Conduct assays and lab procedures following cGMP and SOPs.
• Ensure accuracy and compliance of all analytical data and documentation.
• Maintain training, testing, documentation and lab maintenance per industry standards and regulations.
• Prepare validation documents for new products, changes and qualifications.
• Mentor new staff on established work processes and assays.
• As FL or co‑FL, lead a project team of 2–3 people with clear roles.

Skills

Project leadership

Training others

SOP drafting

Data analysis

Root cause analysis

Documentation

Team leadership

Education

Bachelor's degree with 4–6 years experience

Master's degree with 2–4 years experience

Job description

Job Title

Scientist I, QC

Work Location

Cranbury, NJ

Job Summary

We are seeking a self‑motivated professional to fill the role of Scientist I in our QC department at the New Jersey site. The successful candidate will provide method transfer, validation documentation, and conduct assays and lab procedures in compliance with cGMP guidelines and internal SOPs. The position involves close collaboration with internal teams and clients to ensure timely project deliveries.

Job Responsibilities

• Ensure successful method transfer, including training of personnel for execution and review, review of data, and completion of documentation.
• Conduct assays and lab procedures in compliance with cGMP guidelines and internal SOPs, including Protein Concentration by A280, SEC‑HPLC, peptide mapping, N‑glycan, CE‑SDS NR/R, iCIEF.
• Ensure that all analytical data from the laboratory is accurate, precise, robust and generated by following methods, specifications and procedures.
• Ensure compliance with training, testing, documentation and general lab maintenance requirements for industry standards and/or regulations.
• Prepare validation documents to support new products, process changes and qualifications.
• Introduce established work processes and standard operations to new employees to help them complete their tasks; able to train others on intermediate assays.
• As FL or co‑FL, lead a project team of 2–3 people and ensure clear division of labor and responsibilities.

Qualifications

• Full‑time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors. Bachelor's degree: at least 4–6 years of experience in the professional field. Master’s degree: at least 2–4 years of experience in the professional field.
• Knowledge and experience in analytical and QC operations of the pharmaceutical industry, understanding current regulations and industry trends of biologics product development, characterization and manufacturing testing requirements including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
• Experience in analytical development or quality control operation to support clinical or commercial scale manufacturing product testing.
• Experience with modern analytical instruments for protein analysis, such as Size Exclusion Chromatography, Peptide Mapping, Polysorbate 20/80 Quantitation, Capillary Electrophoresis, Imaged Capillary Isoelectric Focusing (iCE3 and Maurice), Protein Concentration by A280.
• Ability to process, evaluate and summarize technical data, and draft method qualification/transfer protocols and reports, analytical procedures, data summary and assay performance data trending analysis report.
• Experience with method qualification or validation.
• Ability to generate protocol and report independently.
• Ability to lead analytical support for multiple iCMC and standalone projects.
• Ability to draft and review SOP or AMP for operating equipment and performing analytical testing.
• Ability to document and review experiments following GDP and ALCOA+ principles.
• Ability to perform and review data analysis independently.
• Ability to lead root cause analyses.
• Ability to lead the investigation of quality events, including lab investigation and deviation.
• Ability to answer audit questions and address audit comments.
• Ability to manage timeline and resources for project support.
• Ability to lead a team of Associate Scientist and Scientist to perform tasks.