Scientist I, PCT Quality Control

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

Job Summary

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

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 New Jersey site. The successful candidate will provide successful method transfer, validation documentation, and conduct assays and lab procedures according to and in compliance with cGMP guidelines and internal SOPs. The position involves close collaborations 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 according to and 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 is 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 clear 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 pharmaceutical industry, understand current regulations and industry trends of biologics product development, characterization and manufacturing testing requirement including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance1.
• Experience in analytical development or quality control operation to support clinical or commercial scale manufacturing product testing.
• Experience in 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. Ability to 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.

Job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability