Job Opportunity

Job Opportunity

Scientist II, PCT Quality Control

Scientist II, PCT Quality Control

United States Posted 2026-03-02

Job Title - Scientist ll, PCT Quality Control

Work Location - Cranbury NJ

Responsibilities

As Scientist for testing:

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.

As Subject Matter Expert:

Generate documents such as, SOPs, analytical methods, and On The Job training and trains junior staff on methods.
Optimize methods to improve efficiency while adhering to Quality Control standards.
Troubleshoot any issues on assays, instrument, or reagents.
Investigate any OOS/OOT and atypical results and laboratory investigations, conduct root cause analysis, and implement CAPA .
Attend internal and external meetings and present data summary, investigation results, or trending analysis to project teams or clients.
Proactively respond to and participate in scheduled audits and able to defend methodologies to auditors.

Qualifications

Education and Experience:

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 expeirence in field
Master's degree: at least 2-4 years of experience in field
PhD: No requirement

Technical Skills / Knowledge:

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.

Problem Solving:

Proven experience in risk mitigation planning and ability to solve complex QC technical and operation problems. Be able to make appropriate judgment and decisions based on available knowledge and data to ensure the safety and success of the manufacturing support and product testing.

Communication Skills:

Proficiency in English is required. Excellent communications skills (verbal, written, and presentation skills). Must be able to collaborate with clients, internal stakeholders, and support functions to achieve alignment and work effectively.

The anticipated salary range for this position is $60,000 - $96,000

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.

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