Senior Manager, Biologics Analytical Development (CMC Attribute Science)

Location: Remote within the United States

Salary: $150,034–$224,250 annually, plus incentive opportunity

Company

hirify.global develops and commercializes pharmaceutical products, including biologics.

What you will do

• Integrate, analyze, visualize, and interpret CMC data across early, late-stage, and commercial biologics development.
• Aggregate and trend analytical, process, stability, and comparability datasets to support CMC decisions and regulatory strategy.
• Apply statistical and scientific methods to evaluate variability, trends, and comparability across manufacturing changes and lifecycle events.
• Translate complex datasets into regulatory narratives, risk-based control strategies, and defensible CMC conclusions.
• Partner with Analytical Development, Process Development, MSAT, Quality, and Regulatory Affairs teams to connect process performance with product quality attributes.
• Review external laboratory and CDMO data, reports, transfers, and reconciliation activities for scientific accuracy, traceability, and regulatory readiness.

Requirements

• Master’s degree in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or a related discipline.
• 5–10 years of experience supporting IND and BLA submissions, including data presentation and regulatory narratives.
• Demonstrated experience applying CMC data analytics to comparability assessments, control strategies, and regulatory filings.
• Strong understanding of biologics CMC analytical methods and data types, including purity, potency, identity, and stability.
• Experience with statistical analysis, data trending, and visualization in a regulated environment.
• Knowledge of CMC data integrity, traceability, lifecycle management, and regulatory expectations.

Culture & Benefits

• Remote work arrangement for the United States.
• Medical, dental, vision, and prescription drug coverage.
• Company-provided life and disability insurance.
• Tuition reimbursement and student loan assistance.
• 401(k) match, flexible time off, paid holidays, and paid leave programs.