Cryoport Systems is the life science industry’s 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 is responsible for managing engineering product development projects from inception through successful commercial launch which includes the full range of solutions in the Cryoport product Portfolio. This role will focus on driving multiple and complex product development projects, including design, manufacturing, and integration. Role may also lead some sustaining projects, as required.
PRIMARY RESPONSIBILITIES (include but are not limited to):
- Lead Product Development (PD) cross-functional teams in the execution of PD projects and programs from initiation through to transfer 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, budget, 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 NPD project plans which align to NPD 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 a 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 insufficiencies.
- 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.
- 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 versus projected metrics, and determine the overall efficiency of the project.
- 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.
COMPETENCIES:
- 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.
- Experience with PPM Tools (e.g. Clarizen/Planview) is advantageous.
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.
- Certificate in Program Management (PgMP) or Portfolio Management (PfMP) preferred.
- Minimum 8-10 years of experience in the development and commercialization of technical/engineering/industrial/wireless consumer products.
- Experience in managing projects in FDA-regulated industry or comparable experience in other regulated environments.
- Experience in the medical device industry and compliance with internal Quality Systems.
Compensation: Up to $140,000 base salary (depending on experience) + bonus, stock, 401k match, and benefits.
Cryoport is an Equal Opportunity employer offering competitive compensation and exceptional benefits including health, dental, vision, disability insurances, 401K match and company equity (Nasdaq:CYRX).
What We Do
Cryoport Systems is a market leader in globally integrated temperature-controlled supply chain support for critical, irreplaceable products and materials in the Life Sciences industry. We are already trusted to support over 650 active clinical trials and we support the leading commercial therapies worldwide, delivering unparalleled, integrated supply chain services for products, therapies and treatments requiring unique, specialized temperature-controlled management. As the Life Sciences constantly evolve and advance, so do we.