Scientist I, PCT Quality Control

About the role

We are seeking a self‑motivated professional to fill the role of Scientist I in our QC department at the New Jersey site. The successful candidate will provide method transfer, validation documentation, and conduct assays and lab procedures in compliance with cGMP guidelines and internal SOPs. The position involves close collaborations with internal teams and clients to ensure timely project deliveries.

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 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; train others on intermediate assays.
• As functional lead or co‑functional lead, manage a project team of 2‑3 people, defining clear division of labor and responsibilities.

Qualifications

• Full‑time undergraduate degree or above in biology, chemical engineering, chemistry, pharmacy or a related field.
• Bachelor’s degree: 4–6 years of relevant professional experience.
• Master’s degree: 2–4 years of relevant professional experience.
• Knowledge and experience in analytical and QC operations of the pharmaceutical industry, including current regulations and industry trends for biologics product development, characterization, and manufacturing testing (cGMP, ICH, EMA, FDA, and other global compendia).
• Experience in analytical development or quality control supporting 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.

Skills

• Ability to process, evaluate, and summarize technical data.
• Ability to draft method qualification/transfer protocols and reports, analytical procedures, data summaries, and assay performance trending analyses.
• 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 and investigations 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.