Senior Manager, Program Management and Drug Substance Lead
Vor Bio
10 hours ago
Remote friendly (Boston, MA)
United States
Operations
Senior Manager, Program Management & Drug Substance Lead
Roles and Responsibilities
- Program Management & Execution: Drive day-to-day program execution across drug substance activities; develop and maintain integrated timelines; track deliverables, risks, and dependencies; ensure alignment across CMC, Quality, Regulatory, Clinical, and Supply Chain.
- Drug Substance Development & Manufacturing: Support drug substance activities for biologics (including CHO cell line–based processes); contribute to process development, tech transfer, scale-up, and manufacturing readiness; partner with technical teams to ensure processes are robust and aligned with program timelines.
- External Manufacturing Coordination: Coordinate activities across CDMOs and external partners; track manufacturing progress; ensure deliverables meet expectations; escalate risks/issues; support manufacturing campaign preparation and monitor execution.
- Supply Planning Alignment: Partner with Supply Chain to align drug substance manufacturing with clinical and commercial demand; support production scheduling, inventory tracking, and risk mitigation for supply continuity.
- Risk Management & Issue Resolution: Identify program/technical risks and support mitigation plans; resolve manufacturing, process, or supply issues cross-functionally in a timely manner.
- Cross-functional Collaboration: Coordinate with Quality, Regulatory, Clinical, Commercial, and Finance; support regulatory documentation and consistency of CMC information.
- Program & Data Management: Maintain program plans, trackers, and dashboards (e.g., Smartsheet) and provide clear updates/reporting.
Skills & Competencies
- Program Execution: Manage timelines and deliverables in a fast-paced environment.
- Technical Foundation: Knowledge of biologics drug substance development (CHO cell culture; upstream and downstream processes).
- Cross-functional Collaboration: Manage competing priorities.
- Problem Solving: Analytical mindset; identify risks and support practical solutions.
- Communication: Clear, organized, concise stakeholder updates.
Education, Experience & Qualifications
- Bachelor’s degree in life sciences, engineering, or related field; advanced degree preferred.
- 6–10+ years of experience in biologics drug substance development, manufacturing, or CMC program management.
- Required: Experience with CHO cell-based manufacturing systems.
- Working knowledge of upstream (cell culture) and downstream (purification) processes.
- Experience supporting tech transfer, scale-up, and manufacturing execution.
- Experience working with external manufacturing partners (CDMOs).
- Strong program and data management skills; Smartsheet experience preferred.
Benefits (if applicable)
- Comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). Education assistance, wellness resources, and financial security.
Compensation
- Salary range: $155,000–$175,000 per year (varies by factors including skills, experience, education, market, and work location).
Roles and Responsibilities
- Program Management & Execution: Drive day-to-day program execution across drug substance activities; develop and maintain integrated timelines; track deliverables, risks, and dependencies; ensure alignment across CMC, Quality, Regulatory, Clinical, and Supply Chain.
- Drug Substance Development & Manufacturing: Support drug substance activities for biologics (including CHO cell line–based processes); contribute to process development, tech transfer, scale-up, and manufacturing readiness; partner with technical teams to ensure processes are robust and aligned with program timelines.
- External Manufacturing Coordination: Coordinate activities across CDMOs and external partners; track manufacturing progress; ensure deliverables meet expectations; escalate risks/issues; support manufacturing campaign preparation and monitor execution.
- Supply Planning Alignment: Partner with Supply Chain to align drug substance manufacturing with clinical and commercial demand; support production scheduling, inventory tracking, and risk mitigation for supply continuity.
- Risk Management & Issue Resolution: Identify program/technical risks and support mitigation plans; resolve manufacturing, process, or supply issues cross-functionally in a timely manner.
- Cross-functional Collaboration: Coordinate with Quality, Regulatory, Clinical, Commercial, and Finance; support regulatory documentation and consistency of CMC information.
- Program & Data Management: Maintain program plans, trackers, and dashboards (e.g., Smartsheet) and provide clear updates/reporting.
Skills & Competencies
- Program Execution: Manage timelines and deliverables in a fast-paced environment.
- Technical Foundation: Knowledge of biologics drug substance development (CHO cell culture; upstream and downstream processes).
- Cross-functional Collaboration: Manage competing priorities.
- Problem Solving: Analytical mindset; identify risks and support practical solutions.
- Communication: Clear, organized, concise stakeholder updates.
Education, Experience & Qualifications
- Bachelor’s degree in life sciences, engineering, or related field; advanced degree preferred.
- 6–10+ years of experience in biologics drug substance development, manufacturing, or CMC program management.
- Required: Experience with CHO cell-based manufacturing systems.
- Working knowledge of upstream (cell culture) and downstream (purification) processes.
- Experience supporting tech transfer, scale-up, and manufacturing execution.
- Experience working with external manufacturing partners (CDMOs).
- Strong program and data management skills; Smartsheet experience preferred.
Benefits (if applicable)
- Comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). Education assistance, wellness resources, and financial security.
Compensation
- Salary range: $155,000–$175,000 per year (varies by factors including skills, experience, education, market, and work location).