Scientist II, PCT Quality Control

Scientist II, PCT is a member of the physicochemical testing team of the 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 serve as the Subject Matter Expert for one or more QC disciplines. Strong oral and written communication skills are required, along with active involvement in training, report generation, troubleshooting, investigation, and documentation.

Responsibilities

• Ensure successful method transfer, including training of personnel for execution and review, data review, 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, and iCIEF.
• Ensure all analytical data from the laboratory is accurate, precise, robust, and 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 and train others on intermediate assays.
• As FL or co-FL, lead a project team of 2-3 people, ensuring clear division of labor and responsibilities.

Qualifications

• Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy, or related fields.
• 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 experience requirement.
• Knowledge and experience in analytical and QC operations of the pharmaceutical industry, with an understanding of current regulations and industry trends for biologics product development, characterization, and manufacturing testing requirements, including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
• Experience in analytical development or quality control operations to support clinical or commercial-scale manufacturing product testing.
• Experience with 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), and Protein Concentration by A280.
• Ability to process, evaluate, and summarize technical data.
• Ability to draft method qualification/transfer protocols and reports, analytical procedures, data summaries, and assay performance data trending analysis reports.
• Experience with method qualification or validation.
• Ability to generate protocols and reports independently.
• Ability to lead analytical support for multiple iCMC and standalone projects.
• Ability to draft and review SOPs or AMPs 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 investigations and deviations.
• Ability to answer audit questions and address audit comments.
• Ability to manage timelines and resources for project support.
• Ability to lead a team of Associate Scientists and Scientists to perform tasks.

Pay

The anticipated salary range for this position is $66,200 to $105,900.