QC Senior Scientific Reviewer

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

The Quality Control Scientific Reviewer provides independent, data-driven review and oversight across in-process, release, and stability testing. The role includes technical writing of methods, protocols, reports, and investigations. It integrates data reviews and trend analysis, and document quality assurance to support manufacturing, qualification, and lifecycle management of methods, materials, and products.

• Perform data reviews/analyses, track metrics, and identify trends to inform release decisions, stability conclusions, and risk assessments.
• Oversee drafting, reviewing, and approval of technical documents (protocols, SOPs, URS, trend reports, change controls, CAPAs, investigations) for regulatory readiness.
• Facilitate collaborative approval workflows for documents, coordinating with third parties as needed.
• Produce and quality-check reports, trend analyses, and investigative summaries; maintain traceability and audit readiness.
• Conduct USP/JP/EP/Eurachem compliance reviews; support regulatory submissions and internal audits.
• Lead CAPA generation and closure documentation, Out of Specifications, Out of Trend, GCC, and deviations; investigate with root-cause analysis and preventive actions.
• Manage stability programs and studies (forecasts, scheduling, timelines); provide stability/testing planning (protocols, strategies, data interpretation).
• Engage cross-functionally on data-driven decisions; support raw material qualification; compile GMP data for COA; serve as client-facing scientific reviewer/writer.

• Bachelor’s Degree in Chemistry, Analytical Science, or related Life Science Discipline and 9+ years in GLP/GMP analytical environments in Quality Control or Process and Development.
• Master’s Degree in Chemistry, Analytical Science, or related Life Science Discipline and 7+ years in GLP/GMP analytical environments in Quality Control or Process and Development.

• Detail-driven, data-focused professional who conducts independent review and oversight of stability, testing, and technical documentation to ensure scientific rigor, regulatory compliance, and timely decision-making.
• Strong data interpretation, method monitoring, and documentation quality assurance to support material and product lifecycle activities.
• Experience with or understanding of analytical methods such as UHPLC, CE-SDS, ELISA, PCR (ddPCR & qPCR), and Cell Culture.
• Academic or industry-based background in Virology.
• Strong critical and analytical thinking skills for effective problem-solving and outcome improvement.
• Knowledge of cGMP manufacturing and quality systems within an FDA-regulated environment and ICH quality guidelines.
• Technical skills: proficiency in analytical techniques (ELISA, HPLC/UPLC, qPCR/ddPCR, spectroscopy, cell-based assays); method validation/transfer; data trending and statistics; instrument maintenance; basic programming or data analysis tools a plus.
• Regulatory/Quality: knowledge of cGMP, ICH guidelines, and QA/QC systems; experience with regulatory submissions and deviations/CAPAs.
• Soft skills:
  
  excellent scientific communication (written and oral), problem-solving, collaboration, adaptability, and mentoring ability.
• Biologics/Virology background; experience with microbial testing, QA release testing, and GMP documentation.

Pay Range for this position: $66,200–$99,300.

Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.