Operational Readiness Director, Large Scale Allogenic (Biotech)

 

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

Check out this video about what a career at our Portsmouth NH facility could look like for you: Your Career with Lonza in Portsmouth, NH (youtube.com)

• Lonza is building a large-scale dedicated facility to allogenic product for a key customer. Operational readiness director play a key role during our site start up, leading the planning, coordination, execution and tracking of cross-functional activities for our operational readiness team, as well as ensuring integration and alignment with Construction and Commissioning/Qualification workstreams.
• Main responsibilities include developing, coordinating and integrating operational readiness plans for multiple workstreams, facilitating cross functional activities execution, resolving execution challenges, planning resources, managing actively schedule and risk,  ensuring partner alignment, tracking performance, and documenting lessons learned.
• Operational readiness director will be responsible and accountable for operational readiness of the large scale dedicated facility for GMP manufacturing, process validation runs and subsequent commercial manufacturing.
• Lead and facilitate cross-functional workshops required to ensure project alignment, solve project challenges, identify gaps and advance site strategy

• Develop specific operational readiness plans, schedules and risk registers for multiple workstreams such as Manufacturing
• Engineering, Technical, Process Development, Supply Chain, Quality Assurance and Quality Control, among others
• Integrate and actively facilitate workstreams execution by close schedule monitoring, and facilitation of execution forums
• Ensure internal alignment of operational readiness schedules, as well as externally with construction and commissioning/qualification workstreams
• Execute project resources planning, negotiation, reconciliation and reporting
• Drive project communication strategy, with standardized progress tracking tools and processes for proactive monitoring, management and reporting of project deliverables
• Provide strategic guidance on overall project delivery to de-risk and optimize execution
• Resolve workstream issues arising throughout the project, manage risk register, and escalate when appropriate to keep objectives and deliverables on track
• Establish and maintain a positive working relationship with customers, other Lonza departments, and stakeholders.  
• Perform other duties as assigned

• Challenges others to work differently when the business environment requires it•  Manages ambiguity through effective communication, removes barriers and overcomes resistance skillfully

• Translates corporate strategy into critical success factors and creates effective implementation plans
• Acts as a key communication link between operational layers and upper management
• Demonstrates timely and accurate decision making, ensuring delegation or escalation where appropriate

• Develops inclusive relationships and alliances engaging internal and external stakeholders
• Creates mechanisms to share information and knowledge across Functions Builds and effectively manages diverse teams to enhance Lanza's global competitiveness and innovation

• Finds the right balance between customer needs and business goals
• Manages interactions proactively to drive customer satisfaction
• Communicates regularly with peers/team members about customer topics to drive awareness and build capability

• Ensures that teams support the execution of business strategy and/or specific objectives
• Assure pragmatic problem solving is carried out with a strong sense of purpose and urgency and notify/make recommendations to Management regarding serious compliance or quality issues. Routinely report on quality . and compliance issues
• Leads multiple complex initiatives simultaneously to successful conclusion
• Provides coaching to enable/accelerate success outcomes•   Anticipates and resolves challenges

• Demonstrated leader in the field with sustained performance and accomplishments. Ability and experience in turning around and remediating . compliance challenges. Ability to plan and budget at a senior level.    Demonstrates high integrity and accountability for his/her area ensuring team(s) actions and decisions are aligned to business objectives
• Provides opportunities for talent and performance development through specific and measurable actions, coaching and mentoring
• Seeks feedback to understand impact on others; knows his/her own strengths and limitations, learns from mistakes

Skills

• Strong and proactive leader who provides direction, sets high expectations, and measures performance
• Ability to translate strategic objectives into practical executable plans•Provides clear definition of workstream scope, roles and responsibilities, and resolves disputed areas
• Ability to build working relationships and effective partnerships at all levels in the organization
• Active communicator which communicates effectively with Project Team, Workstream Leaders, Site Leadership Team, and external partners
• Proactive, self-starter with the ability to take on several projects at one time, manage workstream level daily tasks, as well as owning a program with cross-functional projects
• Expertise running large scale projects within a matrix organization•Ability to work to tight deadlines in a fast-moving environment•Strong ability to negotiate and influence
• Data driven decision maker and problem solver, with strong analytical skills•Understanding of operational excellence, including continuous improvement methodologies (e.g. Lean, Six Sigma, etc.)
• Regulatory knowledge for Biologics, or Cell and Gene products.
• Strong knowledge of current industry trends and has the ability to use the latest technologies
• Excellent organizational and computer software skills