Associate Director, CMC Ops — Multi-Program Pharma PM

Kailera Therapeutics, Inc.; United States; Híbrido; USD 155.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health coverage

401(k) match

Tuition reimbursement

Commuter benefits

Wellness stipend

Equity grants

Annual bonus opportunities

Descripción de la vacante

Kailera Therapeutics, Inc. is seeking an Associate Director of CMC Operations to drive planning and execution across multiple development programs.

This hub-based role supports cross-functional teams, manages integrated CMC timelines, and coordinates with CDMOs for tech transfers and manufacturing campaigns. The role emphasizes risk management, budget forecasting, and collaboration with Quality, Regulatory, Clinical, and Finance to meeting project milestones and regulatory expectations.

Formación

• 10+ years in pharmaceutical drug development
• 5+ years in CMC project management or related program management
• Experience managing work with CDMOs
• Advanced proficiency in Smartsheet with integrated timelines
• Experience with project budgets, forecasting, and expense tracking
• Excellent communication, facilitation, and presentation skills with senior leadership
• Proven track record in cross-functional and cross-cultural teamwork

Responsabilidades

• Lead planning and execution of CMC workstreams across development programs, from technical development to regulatory submission and product approval
• Build and maintain integrated CMC project plans and timelines in Smartsheet
• Lead cross-functional Technical Operations Program Teams: set agendas, drive decisions, track actions, risks, and issues
• Coordinate activities with CDMO partners for transfers and manufacturing campaigns
• Identify, assess, and mitigate project risks and dependencies, develop contingency plans
• Coordinate CMC contributions to regulatory submissions and timelines
• Collaborate with QA, Regulatory, Clinical Supply, and Finance to maintain efficient product development and budget practices
• Communicate project status and key issues to management and project teams via dashboards and governance updates

Conocimientos

CMC project management

Cross-functional leadership

Smartsheet mastery

Budget forecasting

Communication

Risk management

Presentation skills

Interdisciplinary teamwork

Educación

Bachelor’s degree in a scientific discipline

Advanced degree preferred

Herramientas

Smartsheet

Descripción del empleo

Kailera Therapeutics, Inc. is seeking an Associate Director of CMC Operations to drive planning and execution across multiple development programs.

This hub-based role supports cross-functional teams, manages integrated CMC timelines, and coordinates with CDMOs for tech transfers and manufacturing campaigns. The role emphasizes risk management, budget forecasting, and collaboration with Quality, Regulatory, Clinical, and Finance to meeting project milestones and regulatory expectations.