Project Director, Peptide API

Purpose:

The Project Director will drive transformational performance in delivery of Peptide API projects in the United States through adoption of best-in-class technology, cross-functional alignment with Operations and external functions, seamless execution and delivery of projects with manufacturing sites and reduce overall project timeline to deliver products to patients. Adoption of first-time process technologies and modality with a change readiness mindset is critical to this role. This role requires cross-functional collaboration with other functions during all phases of the development of strategic projects. The incumbent will provide key technical inputs to business development activities involving external pipeline and new modalities, in addition to ensuring manufacturing capacity for product growth and internal pipeline. The incumbent will report to VP, Strategic Capital Deployment in the Operations Transformation organization.

Responsibilities:

Lead a team of professionals to achieve the charter, priorities and milestones of strategic peptide manufacturing project within the US. Lead and manage complex and strategically critical capital projects to ensure timely delivery of project milestones in a compliant and efficient manner. Responsible for compliance to EHS standards and ensure Zero incidents or non-conformances during construction of all the projects. Develop strategies to efficiently deliver concept studies, basic and detailed design, procure capital equipment and contract construction services. Drive transformation across all phases of the projects to deliver best-in-class technology, efficiency in execution to reduce the overall project line up to 20% from the baseline, introduce AI and digitalization in various aspects of project management and development. Direct all phases of the project development from initiation of the business case/Request for Capital through contract negotiation, cost accountability and program execution ensuring adherence to company standards, competitive pricing, and manufacturing schedules, if in a brownfield development. Responsible to meet the key intent of the projects - best-in-class design, on time delivery, delivery of scope on or below budgeted cost and conformance to quality requirements. Develop and implement comprehensive risk management strategies to mitigate potential issues during development of projects. Drive KPIs to measure and monitor performance of strategic projects in the US, effectively communicate performance and risks to the steering committees and ensure top-tier governance of the projects. Collaborate with internal teams including procurement, quality assurance, PDS&T, ME&C and R D to ensure alignment and efficiency in decisions that impact project priorities. Partner with stakeholder groups to facilitate resolution of process, technical or quality issues Develop a sourcing strategy with procurement and be responsible to manage relationships with consultants, Architectural/Engineering firms, construction contractors including participation in project review meetings, contract negotiations and dispute resolution. Develop estimates and plans along with any technical and financial analysis such as ROI/NPV for new projects to be planned. Develop Long Range Plans that include capital and project estimates and scope required to support internal manufacturing of pipeline products or established products that need new or additional manufacturing capacity. Qualifications BS, Engineering or equivalent technical degree; Master's degree in Engineering or MBA preferred Minimum of 15+ years of experience as a Senior Engineering / Projects / Operations Leader across multiple technologies. In-depth technical and operational expertise across majority of manufacturing technologies including Biologics BDS/BDP, Small Molecule API/OSD, Medical Device, and Packaging Operations. Proven inclusive management and leadership capabilities of large cross-functional teams and the ability to effectively interact and communicate with senior leadership and executives from strategic partners and authorities. Outstanding negotiation skills and knowledgeable and experienced functional responsibility of diverse functions required for successful operations including Manufacturing, Quality, Supply Chain, Engineering and Financials. Proven ability to lead and develop high-performing teams in a global matrixed organization. Ability to lead change and deliver results across a matrix organization. Business acumen and direct financial planning/budgeting experience required including P&L responsibility. Highly articulate with strong verbal and written communication skills Ability to mentor and develop next generation of leaders Frequent travel to project sites within the US and to design reviews/workshops outside the US will be required

Key Stakeholders:

ME&C, PDS&T, R

D, Procurement, Global Engineering, EHS, Facilities, AI and Digital Transformation, Government Affairs