Senior Manager, Biologics Analytical Development (CMC Attribute Science)
About The Position
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.
Requirements
- 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.
- Proven 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.
Responsibilities
- Execute and support integration, analysis, visualization, and interpretation of CMC data across development stages (early, late, and commercial).
- Aggregate 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.
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
