Director, R&D Operations

Terumo BCT, Inc. • Denver, CO

1d

About The Position

The Director of R&D Operations is a strategic technical leader responsible for ensuring products and processes are designed for world-class manufacturability, quality, and operational performance.  This role drives integration of Design for Manufacturing (DFM), Design for Assembly (DFA), and Design to Cost (DTC) principles across the full product lifecycle and product portfolio.  Beyond traditional DFM roles, the Director of R&D Operations also oversees pharmaceutical development, and global R&D laboratory operations ensuring disciplined test strategies are executed supporting the manufacturability and quality of current and future products.
This leader partners closely with R&D, Quality, Supply Chain, and Operations to identify risks early and to optimize both design transfer to manufacturing and improvement to on-market products.  Provides strategic direction to projects aimed at increasing market share, reducing cost, driving product quality, continuously expanding R&D’s capabilities. Develops objectives, plans, and strategies to ensure effective achievement of business objectives as prioritized by Business Areas and Operations. Uses Lean Principles to reduce rework and optimize R&D Operations.  Duties also include budget responsibility and leadership roles across various teams and initiatives within the organization.

Requirements

• B.S. degree in Science or Engineering required.
• Minimum of 20 years’ medical device and pharmaceutical industry.
• Minimum 10 years’ progressive management experience.
• Extensive experience with Pharmaceutical Process Development and Transfer to Manufacturing including:
• Setting and rationalization of in-process, release, and end-of-shelf-life specification.
• Method development and transfer
• Manufacturing and Stability Investigations
• Extensive experience with leading multiple types of laboratories
• Extensive experience leading lab investigations
• In-depth knowledge with pharmaceutical and pharmacopeial methods
• Demonstrated success implementing lean process improvements
• Demonstrated success in organizational cost-savings
• Demonstrated success in advance investigation and problem solving including direct CAPA experience
• Ability to work and lead effectively through international teams,
• Direct experience working in regulated environment with regulatory agencies and evolving regulatory issues.
• Demonstrated ability to lead a multi-discipline engineering and scientific team working on multiple projects.
• Ability to solve practical problems and interpret and communicate complex engineering requirements in a manner that allows maximum product flexibility without compromising quality standard.
• Capacity to define and communicate engineering challenges and provide guidance to top management in developing and implementing positive and proactive solutions. 
• Demonstrated ability to interact productively and to effectively influence peers, external colleagues and senior management.
• Must have expert knowledge of pharmaceutical development and laboratory operations and in-depth practical knowledge of how to apply these principles.
• Knowledge of current FDA regulatory and ISO requirements and trends affecting medical devices.
• Ability to help management team balance technical requirements with business requirements and identify solutions to meet both sets of requirements.
• Willingness to take ownership and accept responsibility for actions and decisions.
• Must be detail oriented, well organized and able to work independently and in teams.
• Strong interpersonal and conflict resolution skills.
• Advanced understanding and application of Pharmaceutical Development, GLP, Design Controls, Quality Management System to product development.
• Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods and coordination of people and resources.
• Demonstrated ability to work collaboratively with business segment, regional, functional product development and operations leaders to establish long term goals for the product development team.

Responsibilities

• Drive collaboration with Operations and Supply Chain to improve the manufacturability of products across the lifecycle
• Uses lean principles to reduce departmental costs and increase value generation.
• Sets strategic direction and ensures execution of lean laboratories operations
• Sets strategic direction and ensures lean execution of pharmaceutical development and lifecycle management
• Set strategic direction and ensures execution of R&D stability program
• Acts as R&D’s Data Czar driving excellence in data integrity, data generation, data analysis, and data based decision making
• Manages direct report project leaders, technical supervisors, scientists, and engineers across multiple sites.
• Leads a cross-functional Product Development team whose members are both direct reports and other associates, both technical and business oriented, from departments across the company.
• Participates in the short- and long-term planning process that establishes technical objectives for a business unit project or functional group.
• Evaluates proposed solutions, adaptations, and modifications to products used globally through technical and managerial expertise.
• Works across diverse regional and functional boundaries to promote collaboration and teamwork.
• Works closely with applicable Business Areas and Operations to establish development priorities and milestones.
• Responsible for creating and tracking the budget including project cost estimation, staffing, and timelines.   Accountable for schedule and budget accomplishment.
• Communicates on all levels with senior management, including technical, strategic, and business.

Benefits

• multiple group medical, dental and vision plans
• a robust wellness program
• life insurance and disability coverages
• a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more
• a 401(k) plan with a matching contribution
• vacation and sick time programs

What This Job Offers

• Job Type: Full-time
• Career Level: Director