Senior Manager, Biologics Analytical Development – CMC Attribute Science

This is a fully remote position, open to applicants in United States.

📋 Description

• Execute and assist with the integration, analysis, visualization, and interpretation of CMC data throughout early, late, and commercial development phases.

• Compile and trend datasets related to analytics, processes, stability, and comparability to inform CMC decision-making and regulatory strategies.

• Utilize statistical and scientific methods to assess variability, trends, and comparability associated with manufacturing alterations and lifecycle events.

• Convert intricate CMC datasets into robust conclusions for internal governance and regulatory submissions.

• Collaborate with Analytical Development to interpret method performance, lifecycle data, and validation results within a CMC framework.

• Work alongside Upstream, Downstream, and MSAT teams to correlate process performance with product quality characteristics.

• Deliver analytical data and insights to aid in the development of control strategies.

• Conduct data analysis to facilitate comparability evaluations for changes in processes, scale-ups, site transitions, and technology transfers.

• Review and assist in evaluating CMC data generated by CDMOs and external testing labs.

• Assess external reports, datasets, and summaries for scientific validity and regulatory compliance.

• Assist in data transfers and reconciliation during technology transitions and manufacturing shifts.

• Act as a subject matter expert in CMC analytics and collaborate across Analytical Development, Process Development, MSAT, Quality, and Regulatory Affairs.

• Ensure data quality, consistency, traceability, and regulatory preparedness for global submissions.

⛳️ Requirements

• M.S. in Analytical Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or a related field.

• 5–10 years of proven experience in supporting IND and BLA submissions.

• Direct involvement in data presentation and regulatory documentation.

• Established history of applying CMC data analytics to support comparability, control strategies, and regulatory submissions.

• Strong comprehension of analytical techniques and data types applicable to biologics CMC, including purity, potency, identity, and stability.

• Experience in statistical analysis, data trending, and visualization within a regulated context.

• In-depth knowledge of regulatory standards for CMC data integrity, traceability, and lifecycle management.

🏝️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Company-funded basic life insurance.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement.

• Student loan assistance.

• Generous 401(k) matching.

• Flexible time off.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.

• Incentive opportunities.