Job Title - Scientist II, PCT Quality ControlWork Location - Cranbury, NJJob Summary:Scientist II, PCT is a member of the physicochemical testing team of QC department to support method transfer, validation, deviation support, and investigation projects. This role is responsible for the quality and on-time delivery of test results, validation data and other QC deliverables to internal and external clients and will be the Subject Matter Expert for one or more of the QC disciplines. Must demonstrate strong oral and written communication skills and actively involve in training, report generation, troubleshooting, investigation and documentation
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 to 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
Job 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.
- PhD: No requirement.
- 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 guidance
- 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. 
