QC PCT/CQV Scientist (4990)

Job Title - Scientist l, QC PCT/CQV

Work Location - Cranbury NJ

Job Summary

The QC Testing Scientist 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.

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
• Prepares validation documents to support new products, process changes and qualifications.
• Handle up to 2 projects at the same time, coordinate the internal and external resources of the project, effectively control the key nodes, progress and deliverables of the project (in line with the scope of the contract).

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:

• Bachelor or advanced Graduate degree (MS/PhD) in Chemistry, Microbiology, Biochemistry or equivalent field.
• A least 9+ years of relevant experience or equivalent for Bachelors', 7+ years for Master's in the Quality Control or related field or equivalent experience.

Technical Skills / Knowledge:

• Candidate must possess 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.
• Solid track record of working experience in quality control operation to support clinical and commercial scale manufacturing product testing and regulatory IND/BLA filing.
• Strong technical and scientific knowledge of general QC testing.
• Hands-on experience in modern analytical instruments for protein analysis, such as Size Exclusion Chromatography, Peptide Mapping, Polysorbate 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 data trending analysis report.
• Provides training on areas of technical expertise and compliance issues relevant to the lab setting.
• Working experience with performing industry investigations/deviations.
• Strong working experience with analytical method validations.
• Working experience with training analysts on new transferred methods.
• Working experience within cGMP industry.
• Previous experience using GMP Quality Systems (ex. TrackWise).
• Experience with lab-based software systems such as: LIMS, Empower, LabX.
• Ability to answer audit questions and address audit comments
• Ability to lead analytical support for multiple iCMC and standalone projects
• Ability to manage timeline and resources for project support.
• Excellent communication skills with the ability to collaborate across multiple teams and projects.
• Experience with speaking publicly. Able to maintain control of meetings as required.

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 pay range for this positon is $60,000-$90,000.

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.