Director, External Development & Manufacturing
About The Position
Our company's Pharmaceutical Sciences and Device Development (PSDD) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench to Good Manufacturing Practice (GMP) manufacturing facilities, our scientists and engineers use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients. The External Development and Manufacturing (ExDM) team within PSDD is focused on executing our company's Research Laboratories drug product and device development sourcing strategy across all phases of small and large molecule research and development operations. The Director, External Development & Manufacturing (ExDM) professional serves as a senior individual contributor responsible for shaping and executing external development and manufacturing strategies across complex drug product programs. This role operates with broad influence across pharmaceutical sciences, driving alignment between internal stakeholders and external partners to deliver high-quality, compliant, and efficient outcomes. The successful candidate will be recognized as a subject matter expert, contributing to strategic direction, vendor network optimization, and enterprise-level process improvements while leading critical initiatives and special assignments.
Requirements
- B.S. with minimum of 14 years relevant industrial experience, or M.S. with 10 years of experience in Chemical Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline.
- Relevant experience in clinical manufacturing, supply chain, or external manufacturing management within the pharmaceutical industry
- Significant experience in pharmaceutical development, manufacturing, or external operations
- Demonstrated expertise in vendor management, program execution, and cross-functional collaboration
- Strong strategic thinking and business acumen
- Proven ability to lead and influence in a matrix environment without direct authority
- Experience driving process improvements and transformation initiatives
- Deep understanding of GMP and regulatory considerations
- Excellent communication, facilitation, and stakeholder engagement skills
- Ability to navigate ambiguity and solve complex problems with creativity and rigor
- Adaptability
- Budget Development
- Chemical Engineering
- Cross-Functional Collaboration
- Cross-Functional Leadership
- Decision Making
- Design
- Facilitation
- Feasibility Studies
- GMP Compliance
- Performance Monitoring
- Pharmaceutical Development
- Pharmaceutical Sciences
- Process Improvements
- Program Execution
- Project Management
- Project Planning
- Regulatory Compliance
- Resource Allocation
- Results-Oriented
- Risk Management
- Stakeholder Engagement
- Strategic Planning
- Strategic Thinking
Responsibilities
- Translate organizational and portfolio priorities into executable strategies across ExDM programs and vendor networks
- Contribute to department and enterprise-level strategic objectives, including alignment of external capabilities with pipeline needs
- Identify opportunities for innovation, operational excellence, and transformation across development and manufacturing processes
- Lead and influence cross-functional initiatives and committees, representing ExDM perspectives in strategic decision-making forums
- Serve as a strategic advisor on complex programs, development strategies, and supply approaches
- Proactively shape and optimize select external vendor networks to meet evolving technical and portfolio requirements
- Develop and maintain strong, trust-based relationships with CDMOs to ensure alignment, performance, and long-term value
- Act as a primary liaison and subject matter expert for key vendors, driving continuous improvement in technical execution and collaboration models
- Evaluate and influence vendor selection, capability assessment, and partnership strategies in collaboration with procurement and partner functions
- Identify, champion, and implement business process improvements across ExDM and at the internal/external interface
- Lead complex, cross-functional improvement initiatives from concept through implementation, ensuring measurable outcomes
- Establish and apply best practices, governance approaches, and standardized ways of working to enhance efficiency and reliability
- Drive a culture of proactive risk management, issue resolution, and continuous learning
- Independently represent ExDM on complex, high-impact programs, ensuring delivery of development and manufacturing objectives
- Manage and influence across multiple stakeholders without direct authority to achieve program goals
- Lead special assignments, including strategic projects, digital initiatives, or transformation efforts that span functions or programs
- Provide expert guidance on technical, operational, and compliance considerations across a broad range of modalities and dosage forms
- Build and sustain strong networks across Development, Finance, Manufacturing, Quality, Procurement, and other key functions
- Facilitate alignment through effective communication, structured governance, and engagement with senior stakeholders
- Present complex ideas clearly, influence decisions, and drive adoption of new approaches or strategies
Benefits
- medical
- dental
- vision healthcare
- other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Director
