Project Manager Senior # 26-23438

• We are seeking a highly capable Senior Project Manager to lead complex technology transfer and commercialization programs across the Drug Substance (DS) Manufacturing network.
• This role combines pharmaceutical drug substance manufacturing expertise, exceptional project management, strategic thinking, digital innovation, and hands-on execution.
• The successful candidate will lead the transfer of drug substance manufacturing processes across external manufacturing sites, drive cross-functional execution, manage technical and operational risks, and ensure the reliable delivery of clinical and commercial supply.
• The role will also champion digital innovation by using data analytics, automation, and digital tools to improve transfer effectiveness, program visibility, proactive risk management, and data-driven decision-making across the manufacturing network.
• The successful candidate must be equally comfortable leading complex technology transfers, managing manufacturing operations, analyzing data, and implementing digital solutions that improve execution across the network.

• Lead complex new product introduction and technology transfer activities for drug substance manufacturing, including new launches and programs transferring into CDMO networks, from development through commercial implementation.
• Serve as the primary program lead, coordinating across Process Development, Quality, Regulatory, Supply Chain, Validation, Engineering, Procurement, and Contract Manufacturing Organizations (CMOs/CDMOs).
• Develop and execute comprehensive technology transfer strategies, integrated plans, schedules, and governance frameworks.
• Drive stage-gate deliverables and maintain alignment with program milestones, budgets, and business objectives.
• Facilitate issue resolution and timely decision-making to maintain project schedules.

• Lead multiple high-priority technology transfer projects simultaneously.
• Build and maintain integrated project plans with clear deliverables, critical-path activities, dependencies, risks, and mitigation strategies.
• Provide executive-level updates on project status, risks, decisions, and resource requirements.
• Drive accountability across cross-functional teams and contract sites to ensure delivery against commitments.
• Anticipate risks and proactively implement mitigation strategies before they become issues.
• Facilitate global meetings, decision forums, and technical reviews.

• Develop and maintain executive dashboards, KPIs, and reporting tools to improve visibility into transfer readiness, milestones, risks, and performance.
• Partner with cross-functional teams to implement digital solutions that improve technology transfer execution and manufacturing performance.
• Use tools such as Power BI, Tableau, Smartsheet, Jira, SAP, Veeva, LIMS, MES, and other data visualization platforms to improve operational effectiveness.
• Analyze process and manufacturing data to identify trends, predict risks, monitor transfer readiness, and improve cycle times.
• Drive standardization and automation across technology transfer processes, governance, reporting, and performance metrics.
• Promote data integrity, governance, and compliance while improving access to manufacturing and project information.

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or a related scientific discipline.

• At least 2 years of direct experience in peptide drug substance manufacturing.
• Strong understanding of cGMP manufacturing and global regulatory requirements.
• At least 2 years of experience leading complex, cross-functional projects involving integrated project schedules, risk registers, executive communications, and external CMOs.
• Proven track record of managing multiple technology transfers and manufacturing programs simultaneously.
• At least 2 years of experience using data visualization, project management, and AI-enabled tools.

• Direct experience with peptide manufacturing.
• Master's degree or PhD in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or a related scientific discipline.
• Experience developing dashboards and analytics tools using Power BI, Tableau, Spotfire, or equivalent platforms.
• Experience using digital tools for project management, manufacturing operations, and technology transfer execution.
• Experience implementing data-driven process improvements and operational excellence initiatives.
• Familiarity with AI-enabled business processes, predictive analytics, and digital manufacturing technologies.
• Strong analytical skills and the ability to translate complex data into actionable business decisions.
• Strong technical understanding of pharmaceutical manufacturing, commercialization, and cGMP requirements.

• Project Management
• Drug Substance Manufacturing
• Power BI

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