Associate Scientist, QC Analyst Training Program

WuXi Biologics; Cranbury Township (NJ); In loco; USD 28.000 - 39.000; Tempo pieno

Descrizione del lavoro

WuXi Biologics invites applications for its QC Analyst Training Program in Cranbury, NJ. The program develops early-career scientists into QC analysts, spanning physicochemical testing, bioassay and impurity analysis for biologics.

Trainees complete theory and supervised lab practice, qualification, and lifecycle activities under cGMP and ALCOA+ data integrity principles. Participants advance through structured modules, including GMP compliance, documentation practices, and method transfer, with

Competenze

• Hands-on laboratory experience through coursework, internships, or work in biotech/pharma.
• Understanding of GMP, data integrity, and Good Documentation Practices.
• Ability to follow controlled procedures and organize scientific data.
• Effective written and verbal communication and ability to work independently in a fast-paced lab environment.

Mansioni

• Complete training curriculum, laboratory rotations, and method qualifications.
• Perform physicochemical, biochemical, bioassay, and residual-impurity testing per approved methods and cGMPs.
• Support in-process, release, stability, characterization, and comparability testing; organize and trend results for assigned procedures.
• Review test records, calculations, chromatograms, and supporting documentation for accuracy and data integrity.

Conoscenze

Laboratory skills

Data integrity

Documentation

Communication

Formazione

Associate or bachelor’s degree in Chemistry/Biochemistry/Biology/Biotech/Pharma/Engineering

Strumenti

Empower

SoftMax

LIMS

Descrizione del lavoro

QC Analyst Training Program

Department: Quality Control

Location: WuXi Biologics, Cranbury NJ

Position Levels: Associate Scientist or Senior Associate Scientist

Candidate Profile: A.S or B.S candiadtes with or without prir industry experience

Hourly Monday through Friday, 9:00am-5:00pm, May have occasional weekend or night shifts

Job Summary

The QC Analyst Training Program develops early-career scientists into qualified Quality Control analysts who can support both physicochemical testing and bioassay and impurity testing for biologic products. Participants complete structured training modules that combine scientific theory with supervised laboratory practice, method-specific qualification, and practical experience with GMP testing, data review, investigations, and laboratory systems. The Associate Scientist or Senior Associate Scientist performs and supports in-process, release, stability, characterization, comparability, and other assigned testing. The role also supports method transfer, qualification, validation, and lifecycle activities while following approved procedures, cGMP requirements, Good Documentation Practices, and ALCOA+ data-integrity principles.

Training Program Structure

Training is organized into required and assignment-specific modules. Each module includes theory, data or case-based instruction, and laboratory practice appropriate to the topic.

• Required scientific foundation: All QC roles complete basic protein chemistry and analytical testing module training, including biotechnology and protein therapeutics, solution chemistry, protein degradation, compendial testing, and key product quality attributes.
• Required compliance foundation: All QC roles complete GMP compliance, Good Documentation Practices, ALCOA+ data integrity, laboratory safety, and controlled laboratory execution training.
• Assignment-specific modules: Separation assay development, bioassay development, and other special-topics modules are assigned according to the candidate’s laboratory assignment at hiring and the methods the individual will support.
• Laboratory practice and qualification: Supervised practice covers equipment operation, sample preparation, controls, system suitability, data processing, troubleshooting, and documented demonstration of readiness before independent GMP execution.

Key Responsibilities

• Complete the assigned training curriculum, laboratory rotations, and method qualifications; maintain current training status for assigned procedures, equipment, and computerized systems.
• Perform physicochemical, biochemical, bioassay, and residual-impurity testing in accordance with approved methods, specifications, laboratory procedures, and cGMP requirements.
• Support in-process, release, stability, characterization, comparability, and other product-testing activities; organize, interpret, trend, and summarize analytical results at the level expected for the assigned position.
• Review test records, calculations, chromatograms, electropherograms, plate data, assay controls, and supporting documentation for accuracy, completeness, data integrity, and compliance.
• Support analytical method transfer, qualification, validation, verification, and lifecycle activities through protocol execution, troubleshooting, data review, training support, and report preparation.
• Operate and care for laboratory instruments; support calibration, preventive maintenance, equipment qualification, troubleshooting, and appropriate control of reagents, standards, samples, materials, and consumables.
• Participate in laboratory incidents, deviations, OOS and OOT investigations, CAPAs, change controls, root-cause assessments, corrective actions, document revisions, and continuous-improvement activities.
• Collaborate with Quality Assurance, Manufacturing, Process Development, MSAT, Analytical Development, Engineering, and other partners; support client-facing PLI gap assessments, audit readiness, and inspection-readiness activities as assigned.

Technical Training and Testing Scope

Bioassay and Impurity Testing (BIT)

• Compendial testing such as pH, osmolality, density, viscosity, HIAC, and etc.
• Protein concentration by A280 and related spectroscopic methods
• SEC-HPLC and other LC methods, including RP-HPLC
• Peptide mapping (LC-UV) and N-glycan analysis
• Reducing and non-reducing CE-SDS
• Imaged capillary isoelectric focusing using iCE3, Maurice, or comparable platforms
• Polysorbate 20 and 80 quantitation
• Additional chromatographic, electrophoretic, and compendial methods as assigned
• Compendial testing such as pH, osmolality, density, viscosity, HIAC, and etc.
• Host cell protein, residual Protein A, residual IgG, and related impurity assays
• Residual host-cell DNA and other qPCR-based assays
• Potency and binding ELISA methods
• Cell-based potency assays
• Plate-reader and plate-washer operation using SoftMax or comparable software
• Cell handling, aseptic technique, assay controls, and acceptance criteria
• Additional biochemical, molecular, and bioassay methods as assigned

Required Qualifications

• Associate or bachelor’s degree in Chemistry, Biochemistry, Biotechnology, Biology, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline; an equivalent combination of education and relevant laboratory experience may be considered.
• 0-2 year of relevant experience for associate level and 2+ years of relevant experience for Sr. associate level.
• Hands-on laboratory experience through academic coursework, research, internships, biotechnology or pharmaceutical work, analytical development, or Quality Control.
• Ability to follow controlled procedures, perform accurate calculations, maintain complete records, and organize and interpret scientific data.
• Understanding of laboratory safety, Good Documentation Practices, data integrity, and the importance of accurate and timely GMP testing.
• Effective written and verbal communication, attention to detail, reliability, learning agility, and the ability to work independently and collaboratively in a fast-paced laboratory environment.

Preferred Qualifications

• Experience with one or more methods or platforms listed in the technical training scope; applicants are not expected to enter the program qualified on both testing tracks.
• Experience supporting biologics testing, clinical or commercial manufacturing, analytical method transfer, qualification, validation, or laboratory investigations.
• Familiarity with Empower or another chromatography data system, SoftMax or other plate-reader software, LIMS, electronic laboratory systems, or electronic quality-management systems.
• Familiarity with OOS, OOT, deviation, CAPA, change-control, audit-readiness, or inspection-readiness processes.

Core Competencies

• Quality and compliance mindset
• Data integrity and documentation excellence
• Scientific problem solving
• Technical learning agility
• Accountability and ownership
• Cross-functional collaboration
• Continuous improvement
• Attention to detail and effective communication

Position does not provide VISA sponsorship.