Cryoport Systems Inc
Senior Program Manager - Facilities
Cryoport Systems Inc, Irvine, California, United States, 92713
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Director, Global Talent Acquisition at Cryoport
Cryoport Systems is the life science industrys most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express shippers, Cryoportal Logistics Management Platform, leading-edge Smartpak Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust. Position Summary This position plays a critical strategic role in enabling product innovation by leading the planning and execution of facility development and readiness initiatives that support operations, product development, testing, and scale-up efforts. Primarily serving as the bridge between physical infrastructure requirements and the dynamic demands of a fast-paced R&D environment (and the design/build process), the Senior Program Manager ensures that facility capabilities align seamlessly with product development timelines and milestones -- from early-stage prototyping through commercialization -- and all projects are tracked for budget, resources, milestones, and timelines. Managing effective, efficient and timely cross-team collaboration and requirements is critical to the success of this role - we look for a bridge builder who can navigate interna and external stakeholders with timely project management, communications and metric tracking. The role is also responsible for managing engineering-driven product development programs across the full Cryoport product portfolio, guiding projects from concept through to successful market launch. This includes oversight of complex and concurrent projects involving product design, manufacturing integration, and facility enablement. In addition, the role may lead select sustaining engineering initiatives as needed to support product lifecycle management and ongoing improvements. Primary Responsibilities include but are not limited to: Work with the cross-functional teams to optimize the processes around facilities approval, design, build, qualify, and change control process around both new greenfield projects as well as modifications to existing facilities. Lead capital improvement and facility buildout projects that support the needs and requirements of functional business units (e.g. Logistics, Consulting, Bioservices & Integricell), R&D labs, pilot production lines, environmental testing chambers, product development/engineering, and/or cleanrooms. Work with internal teams to optimize the requirements definition, validation and sign-off process. Translate product and process requirements into facility design specifications (e.g., utility needs, workflow layout, temperature-controlled spaces). Partner with cross-functional teams (Bioservices, Logistics, Consulting, Integricell, etc.) to plan physical infrastructure to support evolving product pipelines. Oversee request, approval, design, construction, commissioning, and qualification activities in alignment with development timelines. Develop and manage integrated schedules that connect facility readiness with product milestones (e.g., bench testing, pilot runs, clinical builds) and key financial and operational metrics. Ensure facilities infrastructure (e.g., HVAC, lab equipment, production equipment, monitoring systems, etc.) meets regulatory and performance requirements for new products. Anticipate scaling needs and lead space planning efforts to support rapid product growth. Identify and resolve dependencies or bottlenecks between physical infrastructure and product deliverables. Lead Product Development (PD) cross-functional teams in the execution of PD projects and programs from initiation through to transfer to operations, to mature product support. Engage in lead discovery/scoping meetings with support from Product Marketing, Product Management & Business Development to qualify New Product Development projects and identify scope of work, budgets, and timelines - including internal and external team scheduling and coordination - and capture sufficient information to create a formal project plan. Creation and active management of comprehensive, accurate and multi-stakeholder PD project plans which align to PD PMO standards, templates and processes. Lead schedule and budget and scope activities for PD projects and programs constituting the strategic initiatives for the business Portfolio. Use of consistent project management and product development methodologies to maintain accountability of all team members, project budgets and timelines. Develop Key Performance Indicators and project health metrics and maintain these metrics at a project and portfolio basis. Lead product requirements gathering sessions with key stakeholders and ensure core requirements are captured to meet product-specific objectives. Identify major milestones and delivery dates, manage project scope, track progress to detailed schedules including identifying critical path, constraints, contingencies, and mitigations to achieve project objectives. Manage and identify key resource needs across projects and across the product portfolio to ensure project deliverables can be delivered on time and budget with existing resources (or identify need for additional resources or key business leader commitment to have resources needed when required). Deliver regular reports on project and portfolio resource utilization, blockers and insufficiency. Quantify project deliverables and track progress, managing to prevent roadblocks rather than reacting to them. Coordinate resources to ensure established time to market target date is achieved. Develop and maintain initial, monthly, and quarterly operating budgets for each project - including budget vs. actuals along with documented deviations. Develop and maintain initial, monthly and quarterly project summaries, highlighting mitigation options for key issues and risks with team proposed recovery plans. Conduct post project analysis to identify potential improvement in processes, ensure project goals were met, evaluate cost variances, analyze actual verse projected metrics, and determine the overall efficiency of the project. Work collaboratively to share project learnings cross-team to ensure continuous improvement. Escalate threats to project plan as required to functional management and senior leadership. Ability to lead/guide/mentor junior level project managers. Present project updates in global recurring meetings, providing cost/benefit analysis summaries and forecasting models for project resources, budget vs. actual costs, key risks/issues and team Asks. Responsible for timely communication of project status updates, with mitigations to any gaps. Other duties as assigned. Analytical & Management Skills: Capable of quantifying project deliverables into a clear and concise plan. Excellent organizational and problem-solving skills to coordinate product validation activities with in-house Value Engineering team. Excellent communication skills; including interpersonal communication across all levels (team members, team leaders and executive management) and ability to tailor communications to the objective, stakeholder and project. Quality Systems: Understanding of the design control deliverables required of a highly regulated industry. Strong decision making, negotiating and change management skills. Knowledge and experience in the implementation of regulatory requirements for medical device development such as FDA's Design Controls. Strong teamwork/collaboration and influencing skills at levels below, on par and above status. Experience in analyzing tradeoffs between product features, customer needs/requirements, manufacturability, and cost. Experience with schedule, budget, cost, resource, and risk management tracking tools. Ability to facilitate meetings, including creating clear agendas and documenting meeting minutes. Ability to make independent decisions (within established guidelines). Strong working knowledge of commonly used project management software programs. Experience in Stage gate implementations in product development process. Proficient in project management tools (e.g., MS Project, Smartsheet, Jira, Confluence) and documentation control systems. Experience with pharmaceutical, lab and/or manufacturing environments supporting product development (e.g., prototyping labs, pilot lines, cleanrooms). Experience managing complex multi-stakeholder construction and development projects in multiple geographies - with preference for work in logistics and pharmaceuticals. Qualifications and Education Requirements: Bachelor's degree experience in an engineering or technical field. Advanced degree is a plus. Business degree preferred. Certificate in Project Management (PMP) required. Experience engaging with contractors and development partners to deliver facility build out projects on time, on budget, and with the anticipated resources. 7-10 years of experience managing complex product development programs and facilities-related projects in a regulated or technical environment. Experience in managing projects in FDA-regulated industry or comparable experience in other regulated environments Familiarity with GMP, ISO 13485, FDA regulations, or other applicable quality systems Experience in the medical device industry and compliance with internal quality systems Cryoport Systems offers stock, 401k match, tuition reimbursement and strong benefits. Salary: up to $140,000 depending on experience + bonus Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Project Management and Information Technology Industries
Transportation, Logistics, Supply Chain and Storage Referrals increase your chances of interviewing at Cryoport Systems by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Tuition assistance Disability insurance Get notified about new Facilities Manager jobs in
Irvine, CA . Operations Manager ($94,700.00 - $132,400.00)
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Cryoport Systems is the life science industrys most trusted provider of supply chain solutions for temperature-sensitive materials, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. Cryoport Systems' proprietary Cryoport Express shippers, Cryoportal Logistics Management Platform, leading-edge Smartpak Condition Monitoring System and geo-sensing technology paired with unparalleled logistics expertise and 24/7/365 customer support, make Cryoport Systems the end-to-end temperature controlled supply chain partner that you can trust. Position Summary This position plays a critical strategic role in enabling product innovation by leading the planning and execution of facility development and readiness initiatives that support operations, product development, testing, and scale-up efforts. Primarily serving as the bridge between physical infrastructure requirements and the dynamic demands of a fast-paced R&D environment (and the design/build process), the Senior Program Manager ensures that facility capabilities align seamlessly with product development timelines and milestones -- from early-stage prototyping through commercialization -- and all projects are tracked for budget, resources, milestones, and timelines. Managing effective, efficient and timely cross-team collaboration and requirements is critical to the success of this role - we look for a bridge builder who can navigate interna and external stakeholders with timely project management, communications and metric tracking. The role is also responsible for managing engineering-driven product development programs across the full Cryoport product portfolio, guiding projects from concept through to successful market launch. This includes oversight of complex and concurrent projects involving product design, manufacturing integration, and facility enablement. In addition, the role may lead select sustaining engineering initiatives as needed to support product lifecycle management and ongoing improvements. Primary Responsibilities include but are not limited to: Work with the cross-functional teams to optimize the processes around facilities approval, design, build, qualify, and change control process around both new greenfield projects as well as modifications to existing facilities. Lead capital improvement and facility buildout projects that support the needs and requirements of functional business units (e.g. Logistics, Consulting, Bioservices & Integricell), R&D labs, pilot production lines, environmental testing chambers, product development/engineering, and/or cleanrooms. Work with internal teams to optimize the requirements definition, validation and sign-off process. Translate product and process requirements into facility design specifications (e.g., utility needs, workflow layout, temperature-controlled spaces). Partner with cross-functional teams (Bioservices, Logistics, Consulting, Integricell, etc.) to plan physical infrastructure to support evolving product pipelines. Oversee request, approval, design, construction, commissioning, and qualification activities in alignment with development timelines. Develop and manage integrated schedules that connect facility readiness with product milestones (e.g., bench testing, pilot runs, clinical builds) and key financial and operational metrics. Ensure facilities infrastructure (e.g., HVAC, lab equipment, production equipment, monitoring systems, etc.) meets regulatory and performance requirements for new products. Anticipate scaling needs and lead space planning efforts to support rapid product growth. Identify and resolve dependencies or bottlenecks between physical infrastructure and product deliverables. Lead Product Development (PD) cross-functional teams in the execution of PD projects and programs from initiation through to transfer to operations, to mature product support. Engage in lead discovery/scoping meetings with support from Product Marketing, Product Management & Business Development to qualify New Product Development projects and identify scope of work, budgets, and timelines - including internal and external team scheduling and coordination - and capture sufficient information to create a formal project plan. Creation and active management of comprehensive, accurate and multi-stakeholder PD project plans which align to PD PMO standards, templates and processes. Lead schedule and budget and scope activities for PD projects and programs constituting the strategic initiatives for the business Portfolio. Use of consistent project management and product development methodologies to maintain accountability of all team members, project budgets and timelines. Develop Key Performance Indicators and project health metrics and maintain these metrics at a project and portfolio basis. Lead product requirements gathering sessions with key stakeholders and ensure core requirements are captured to meet product-specific objectives. Identify major milestones and delivery dates, manage project scope, track progress to detailed schedules including identifying critical path, constraints, contingencies, and mitigations to achieve project objectives. Manage and identify key resource needs across projects and across the product portfolio to ensure project deliverables can be delivered on time and budget with existing resources (or identify need for additional resources or key business leader commitment to have resources needed when required). Deliver regular reports on project and portfolio resource utilization, blockers and insufficiency. Quantify project deliverables and track progress, managing to prevent roadblocks rather than reacting to them. Coordinate resources to ensure established time to market target date is achieved. Develop and maintain initial, monthly, and quarterly operating budgets for each project - including budget vs. actuals along with documented deviations. Develop and maintain initial, monthly and quarterly project summaries, highlighting mitigation options for key issues and risks with team proposed recovery plans. Conduct post project analysis to identify potential improvement in processes, ensure project goals were met, evaluate cost variances, analyze actual verse projected metrics, and determine the overall efficiency of the project. Work collaboratively to share project learnings cross-team to ensure continuous improvement. Escalate threats to project plan as required to functional management and senior leadership. Ability to lead/guide/mentor junior level project managers. Present project updates in global recurring meetings, providing cost/benefit analysis summaries and forecasting models for project resources, budget vs. actual costs, key risks/issues and team Asks. Responsible for timely communication of project status updates, with mitigations to any gaps. Other duties as assigned. Analytical & Management Skills: Capable of quantifying project deliverables into a clear and concise plan. Excellent organizational and problem-solving skills to coordinate product validation activities with in-house Value Engineering team. Excellent communication skills; including interpersonal communication across all levels (team members, team leaders and executive management) and ability to tailor communications to the objective, stakeholder and project. Quality Systems: Understanding of the design control deliverables required of a highly regulated industry. Strong decision making, negotiating and change management skills. Knowledge and experience in the implementation of regulatory requirements for medical device development such as FDA's Design Controls. Strong teamwork/collaboration and influencing skills at levels below, on par and above status. Experience in analyzing tradeoffs between product features, customer needs/requirements, manufacturability, and cost. Experience with schedule, budget, cost, resource, and risk management tracking tools. Ability to facilitate meetings, including creating clear agendas and documenting meeting minutes. Ability to make independent decisions (within established guidelines). Strong working knowledge of commonly used project management software programs. Experience in Stage gate implementations in product development process. Proficient in project management tools (e.g., MS Project, Smartsheet, Jira, Confluence) and documentation control systems. Experience with pharmaceutical, lab and/or manufacturing environments supporting product development (e.g., prototyping labs, pilot lines, cleanrooms). Experience managing complex multi-stakeholder construction and development projects in multiple geographies - with preference for work in logistics and pharmaceuticals. Qualifications and Education Requirements: Bachelor's degree experience in an engineering or technical field. Advanced degree is a plus. Business degree preferred. Certificate in Project Management (PMP) required. Experience engaging with contractors and development partners to deliver facility build out projects on time, on budget, and with the anticipated resources. 7-10 years of experience managing complex product development programs and facilities-related projects in a regulated or technical environment. Experience in managing projects in FDA-regulated industry or comparable experience in other regulated environments Familiarity with GMP, ISO 13485, FDA regulations, or other applicable quality systems Experience in the medical device industry and compliance with internal quality systems Cryoport Systems offers stock, 401k match, tuition reimbursement and strong benefits. Salary: up to $140,000 depending on experience + bonus Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Full-time Job function
Job function
Project Management and Information Technology Industries
Transportation, Logistics, Supply Chain and Storage Referrals increase your chances of interviewing at Cryoport Systems by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Tuition assistance Disability insurance Get notified about new Facilities Manager jobs in
Irvine, CA . Operations Manager ($94,700.00 - $132,400.00)
Maintenance Supervisor - North Orange County
Sr. Manager, Facilities and Support Teams
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr