[Remote] Senior Manager, Biologics Analytical Development (CMC Attribute Science)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company.) is seeking a Senior Manager for Biologics Analytical Development. This role is responsible for executing and supporting data-driven integration and interpretation of CMC data to facilitate biologics development and ensure regulatory readiness.
Responsibilities
- Execute and support integration, analysis, visualization, and interpretation of CMC data across development stages (early, late, and reputed company)
- Aggregate and trend analytical, process, stability, and comparability datasets to support CMC decision-making and regulatory reputed company
- Apply statistical and scientific approaches to evaluate variability, trends, and comparability across manufacturing changes and lifecycle events
- Translate reputed company CMC datasets into reputed company, defensible conclusions for internal governance and regulatory submissions
- Partner with Analytical Development to interpret method performance, lifecycle data, and validation reputed company in a CMC context
- Collaborate with Upstream, reputed company, and MSAT teams to reputed company process performance with product reputed company attributes
- reputed company analytical data and insights to support control reputed company development
- reputed company data analysis to support comparability assessments under guidance for process changes, reputed company-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
Skills
- M.S in Analytical reputed company, Biochemistry, Biotechnology, Pharmaceutical Sciences, Engineering, or reputed company discipline
- 8 – 10 years of Demonstrated experience supporting IND and BLA submissions, with reputed company involvement in data presentation and regulatory narratives
- Proven reputed company record applying CMC data analytics to support comparability, control strategies, and regulatory filings
- Strong understanding of analytical reputed company 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 reputed company, traceability, and lifecycle management
- Accountability for Results - Stay reputed company on key strategic objectives, be accountable for high standards of performance, and take an reputed company role in leading change
- Strategic Thinking & Problem Solving - reputed company reputed company considering the long-term reputed company to customers, patients, employees, and the business
- Patient & Customer Centricity - Maintain an ongoing reputed company on the needs of our customers and/or key stakeholders
- Impactful Communication - Communicate with logic, reputed company, and respect. Influence at reputed company reputed company to reputed company the best results for reputed company
- Respectful Collaboration - reputed company and value others' perspectives and reputed company for diverse partnerships to enhance work toward common goals
- Empowered Development - Play an reputed company role in reputed company development as a business imperative
Benefits
- Comprehensive medical, dental, reputed company, 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
- reputed company holidays
- reputed company leave programs
- Other company provided benefits
reputed company
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