Job Description

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.

What You Will Achieve

This is a global role with the primary responsibility of leading the Global Engineering Drug Substance Cluster (Grange Castle, Andover, Sanford, Orth, Zagreb, Sanford North, Strangnas). This individual is accountable for delivering the GE support to the Drug Substance Cluster Operations unit.

The Director, Global Engineering Drug Substance Cluster lead, will directly manage a number of Site Global Engineering Leads responsible for providing technical leadership and standardization to the Drug Substance (DS) Cluster OpU.  This role has responsibility for building, leading and maintaining an effective matrix team structure with key partners in Global Engineering and other business partners to effectively prioritize and deliver the OpU business needs. They  will also be a member of the GE SBO leadership team. The DS Cluster lead will work closely with the DS OpU leaders, site leaders, site engineering leaders and other groups in Engineering and Global Technology & Engineering (GT&E) to ensure the success of engineering programs, projects, and the technical support needed for new and marketed products. This leader will have strong connections to and collaborate closely with other enabling functions including Quality, Global Environmental Health & Safety, Global Supply Chain, Procurement, and Finance.

How You Will Achieve It

Role Responsibilities

• Provide support and engineering leadership to the DS Cluster OpU leadership team and the GE DS Cluster team
• Effective stakeholder management.  Communicates proactively with stakeholders regarding activities, progress, issue and resolution plans in relation to capital spend, capital project management and execution, equipment and technical initiatives 

• Lead the Global Engineering DS Cluster team providing strong engineering support to the DS Cluster Operating Unit (OpU) to optimize process robustness and asset performance
• Lead the Global Engineering cross-functional empowered team (matrix team) responsible for setting priorities, the day to day running, effective issue resolution and continuous improvement of the the DS Cluster OpU
• As necessary to ensure all sites are fully supported, act as the Global Engineering Lead to sites in the DS Cluster
• Ensure within the GE team that there is strong technical expertise in Engineering, Maintenance, Asset reliability and Optimization, Utility Operations, NetZero, IFM, MRO Equipment Design, Capital planning and Project Management
• Understand the business needs, develop and ensure that the DS Cluster sites capital plans are meeting the strategic business needs and are aligned with the Site Master Plans, Net Zero plans and site Technology Roadmaps
• Support DS Cluster large capital projects in alignment with the Capital Program Leader
• Develop and lead, in alignment with the OpU leaders and sites, the capital program for the DS Cluster  sites, ~$200M cashflow annually to ensure proper business-driven projects (Maintenance & Strategic) are identified and executed across the Operating Unit

• Manage the Sensitivities throughout the Capital year and work with the site leads and OpU VPs to identify trade-offs and priorities
• Ensure that budgets and LEs for the DS cluster sites are appropriately phased by month based on timing of key operational drivers/milestones

• Review all CPAs >$10M, facilitate stakeholder socialization, contingency and amended CPA requests. Ensure the scopes, estimates, schedules and risks for each CPA are clearly defined and appropriate and allowed for within the CPA
• Perform regular reviews of the capital projects (typically >$10M) in execution phase, focused on project management, risk management, service provider and vendor management, project controls (cost, schedule, procurement) management and doing so across all project execution phases, from concept design through to CQV completion
• Support and guide the sites in the development of  Site Master Plans and support the sustainability master plans
• Define long term engineering requirements for the DS Cluster network
• Partner with the GE Cluster leads and develop standardized support models for Engineering, driving standardization and the one best way approach e.g. SBO Site Engineering Leadership team.
• Champion implementation of Engineering standards and processes for the DS Cluster  network that bring efficiencies and consistency
• Communicate across the organization; foster and promote exchange of information and best practices
• Apply new, innovative and untried approaches to achieve targeted performance and results
• Partner with Global Engineering colleagues to continue to optimize EMU strategies and operational costs
• Ensure a robust talent planning process is in place in Global Engineering and across the engineering teams at the DS sites

Qualifications

• Bachelor Degree in Engineering or equivalent scientific discipline
• Minimum 15 years in pharmaceutical  manufacturing, (biological drug substance manufacturing/ engineering)
• Strong communication skills and the ability to build relationships with colleagues across all levels of the organization, including OpU VP, site leaders  and technical leaders.
• Ability to lead teams, programs and initiatives, fostering support from stakeholders and collaboration among participants.
• The candidate should demonstrate both technical and business skills with the proven capability of effectively implementing business strategies and work collaboratively with all levels of the organization
• The candidate must have had site operational or centre experience in a GMP-regulated environment, involving decision making. The candidate must also have project management experience
• The successful candidate must be flexible with regard to changing and conflicting priorities, able to easily shift gears in terms of behaviour and attitude in response to ambiguity and the needs of the situation. 
• Strong knowledge of drug substance and/or drug product processes and equipment and its application in manufacturing operations
• Appropriate business acumen to lead or provide guidance on equipment, processes, and capital investment strategies.
• MS or MBA desirable

 
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• International travel up to 30%
• Adaptation of schedule to work across different time zones

Relocation support available

Work Location Assignment: Flexible

• Other Job Details:
• Last Date to Apply for Job: April 3, 2023
• Eligible for Relocation Package:  Yes
• Eligible for Employee Referral Bonus: Yes

Relocation assistance may be available based on business needs and/or eligibility.