Associate Scientist, QC Analyst Training Program

QC Analyst Training Program Scientist Location: Cranbury NJ Candidate Profile: A.S or B.S candidates with or withot prior industry experience Hourly, Monday through Friday 9:00 am to 5:00 p.m May have occassional weekend or nght 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

, 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 Physiochemical Testing: 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 Bioassay and Impurity Testing: 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. Salary range for this role is 49,000-79000 The 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