Senior Associate Scientist, QC Testing - Raw Materials & Compendial

Work Location: Cranbury, NJ

About the Role

The QC Micro/RM/Compendial Senior Scientist is responsible for the quality and on-time completion of microbiology, raw material, and compendial testing and sampling. This role ensures QC deliverables to internal departments and external clients are accurate and consistent. The position requires strong oral and written communication skills and active contributions to timely training, report generation, and good GMP documentation and archival.

Responsibilities

• Understand and follow GMP instructions on documents.
• Perform microbiology, raw material, and compendial testing, including but not limited to FTIR, pH, color, clarity, visible and subvisible particles, osmolarity, bioburden, endotoxin, CCIT, etc.
• Conduct environmental monitoring (EM), water, and gas sampling in cleanroom areas across various building sites in Cranbury or other U.S. sites as needed.
• Support raw material sampling and transportation needs across various building sites in Cranbury or other U.S. sites as needed.
• Manage raw material samples, EM monitoring samples, raw material sampling rooms, sample storage rooms, and regulatory retain sample rooms, ensuring proper sampling processes and storage conditions.
• Support reagents and consumables inventory management to ensure consistent QC EM operation needs.
• Record and organize experimental data in accordance with "Good Document Management Practices" to ensure data integrity.
• Ensure compliance with training, preparation, documentation, and general lab maintenance requirements for industry standards and regulations.
• Assist in preparing or executing validation documents to support new materials, process changes, and qualifications.
• Maintain laboratory notebooks and worksheets for QC tasks as required.
• Work weekends and support shift work as needed.
• Perform other duties as assigned by the supervisor.
• As a Subject Matter Expert:
  • Generate documents such as SOPs, analytical methods, and on-the-job training materials, and train junior staff on methods.
  • Optimize methods to improve efficiency while adhering to quality control standards.
  • Troubleshoot issues with assays, instruments, or reagents.
  • Investigate out-of-specification (OOS), out-of-trend (OOT), and atypical results, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
  • Attend internal and external meetings, present data summaries, investigation results, or trending analysis to project teams or clients.
  • Proactively respond to and participate in scheduled audits, defending methodologies to auditors.

Requirements

• Willingness to learn analytical and QC operations in the pharmaceutical industry, with an understanding of current regulations and industry trends in biologics product development, characterization, and manufacturing testing requirements, including cGMP, ICH, EMA, FDA, and other global compendia regulations.
• Basic familiarity with analytical instruments and methodologies such as TOC and conductivity meters is preferred but not mandatory.
• Experience with software and information systems (e.g., Empower, TrackWise, Master Control, LES, lab notebooks, and preferably LIMS).
• Ability to adapt between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
• Strong problem-solving skills, including experience in planning and resolving QC technical and operational issues.
• Ability to raise issues immediately to supervisors and collaborate on solutions.
• Proficiency in English with strong communication skills (verbal, written, and presentation).

Qualifications

• Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy, or related fields.
• Experience requirements:
  • Bachelor’s degree: 9+ years in the professional field.
  • Master’s degree: 7+ years in the professional field.
  • PhD: 2+ years in the professional field.

Pay

The anticipated salary range for this position is $54,700 to $87,500.