Senior Manager, Biologics Analytical Development (CMC Attribute Science)

About the role

The Senior Manager, CMC Data Analytics is responsible for executing and supporting data-driven integration, analysis, and interpretation of CMC data to support biologics development from IND-enabling studies through BLA submission and commercialization. This role serves as a CMC analytics subject matter expert (SME) who partners across Analytical Development, Process Development, MSAT, Quality, and Regulatory Affairs to analyze, summarize, and process datasets into clear regulatory narratives, risk-based control strategies, and informed CMC decisions. The position plays a critical role in ensuring data quality, consistency, traceability, and regulatory readiness for global filings.

Responsibilities

• Execute and support integration, analysis, visualization, and interpretation of CMC data across development stages (early, late, and commercial).
• Agregate and trend analytical, process, stability, and comparability datasets to support CMC decision-making and regulatory strategy.
• Apply statistical and scientific approaches to evaluate variability, trends, and comparability across manufacturing changes and lifecycle events.
• Translate complex CMC datasets into clear, defensible conclusions for internal governance and regulatory submissions.
• Partner with Analytical Development to interpret method performance, lifecycle data, and validation outcomes in a CMC context.
• Collaborate with Upstream, Downstream, and MSAT teams to link process performance with product quality attributes.
• Provide analytical data and insights to support control strategy development.
• Perform data analysis to support comparability assessments under guidance for process changes, scale-up, site changes, and technology transfers.
• Review and support evaluation of CMC data generated by CDMOs and external testing laboratories.
• Review external reports, datasets, and summaries to ensure scientific accuracy and regulatory fitness.
• Support data transfers and reconciliation activities during tech transfers and manufacturing transitions.

Qualifications

• M.S. in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or related discipline.
• 8 – 10 years of demonstrated experience supporting IND and BLA submissions, with direct involvement in data presentation and regulatory narratives.
• Prominent track record applying CMC data analytics to support comparability, control strategies, and regulatory filings.
• Strong understanding of analytical methods and data types used in biologics CMC (e.g., purity, potency, identity, stability).
• Experience with statistical analysis, data trending, and visualization in a regulated environment.
• Solid knowledge of regulatory expectations for CMC data integrity, traceability, and lifecycle management.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company-provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement.
• Student loan assistance.
• A generous 401(k) match.
• Flexible time off.
• Paid holidays.
• Paid leave programs.

Pay

$150,034.00 - $224,250.00, plus incentive opportunity.

Schedule

N/A