Scientist II, PCT QC — Method Transfer Lead

WuXi Biologics

Cranbury Township (NJ)

On-site

USD 66,000 - 106,000

Full time

14 days+

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Job summary

WuXi Biologics in Cranbury, NJ is seeking a Scientist II, PCT Quality Control to support method transfers, validation, deviation investigations, and related QC deliverables. You will be the SME for one or more QC disciplines and contribute to training, reporting, troubleshooting, and documentation.

Responsibilities include leading transfers with personnel training, performing CGMP-compliant assays such as SEC-HPLC and iCE, compiling validation documents, and guiding a 2–3 person project team to

Qualifications

Bachelor’s or higher in biology/chemistry/chemical engineering/pharmacy or related field
4–6 years in professional field for a Bachelor’s degree
2–4 years for Master’s degree
No requirement for PhD
Strong knowledge of cGMP/ICH/FDA regulations and biologics testing

Responsibilities

Transfer methods including training of personnel for execution and review
Conduct assays per cGMP and SOPs (Protein Concentration by A280, SEC-HPLC, peptide mapping, N-glycan, CE-SDS NR/R, iCIEF)
Ensure analytical data accuracy, precision, robustness and documentation
Maintain training, testing, documentation and lab maintenance per industry standards
Prepare validation documents for new products and process changes
Lead/participate in 2–3 person project teams with clear roles and responsibilities
Draft and review SOPs or AMP for equipment and analytical testing