Associate Program Manager-USA

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

The BioServices Associate Program Manager plays a key role in developing and driving strategies, timelines, and resourcing with cross-functional partners to support client relationship development, project, and program planning, and management. This will range from initial discussions with clients, development of the project requirements, documentation aspects of setting up the project and management of all project-related activities through to study completion.

The Associate Program Manager will support the Project Manager to collaborate and coordinate internal teams to meet client expectations as well as company goals. This role is critical in anticipating and mitigating risks to ensure programs are flawlessly implemented and executed to succeed on all 3 constraints (scope, budget, and schedule).

Primary responsibilities include but are not limited to:

• Serve as the central point of contact for clients, or backup, and provide operational support including facilitating program communications internally/externally and leading cross-functional teams to manage multiple project plans and client commitments.
• Manage the delivery of all technical and service aspects of projects and studies for clients.
• Provide data and technical input to the Business Development Manager to help in the creation of proposals.
• Collect all information on a study design including; correct label texts, coordination of secondary

packaging materials and tools, coordination of label production, production/review of all batch

documentation for operations, coordination of shipments through the logistics department, and

preparing and reviewing GMP documents in a timely manner.

• Overall responsibility for ensuring that activities come together in a timely manner to meet the client and study requirements.
• Ensure that risk mitigation plans are implemented to achieve project timelines.
• Establish program schedules for continuous improvement projects such as quality tracking, strategic initiatives, and Business Reviews by assigning key deliverables, metrics and communicating expectations and progress updates.
• Initiate the involvement of appropriate departments, maintaining continuous communication with those departments, and ensure the work delivered to customers is of a consistently high standard.
• Lead the execution of tasks as defined in the project plans to achieve the project goals, and actively identify and manage project risks.
• Monitor and ensure compliance with time and delivery of all contractual commitments as stipulated in client agreements such as MSAs, SOWs and Quality Agreements.
• Support the writing and review of departmental SOPs, Work Instructions & Technical Agreements.
• Attend Project Meetings at the business or customer site. Lead, or support, to represent the business at kick-off meetings, as required by the customer.
• Lead and facilitate customer teleconferences, visits and audits as required, and provide timely

provision of customer reports and updates.

• Interact with Quality Assurance/Regulatory personnel to drive Problem Reports to closure.
• Ensure customer needs are properly translated into quotation and monitor and amend the quote and budget as required.
• Provide accurate and timely financial forecasting, revenue, and reporting.
• Responsible for revenue recognition for projects and verification of final information for Accounting Department, prior to invoice release.
• Ensure all required import licenses, pro-formas, and commercial invoices are prepared as and when required.
• Monitor and record change in the scope of contracts. Arrange for additional invoicing as required. Ensure accurate and regular invoicing is completed.
• Receipt of study related calls / issues. Log calls in system and follow escalation procedure as appropriate. Monitor call logging system to ensure calls are closed out in a timely manner
• Participate in cross-functional business process improvement activities as required.
• Measure project performance using Project Management tools and techniques to monitor the project progress, identify and quantify variances and perform any required corrective actions.
• Work closely with the account manager to gain overall customer satisfaction.
• Set up and maintains study filing systems and maintain accurate records for all work undertaken.
• Assist in setup of client project in Title21 (IMS) and manage material, ensuring Title21 is always current.
• Apply Good Manufacturing Principles (GMP) in all areas of responsibility.
• Good Manufacturing Practice - Investigate and report on internal non-conformances. Assist others in investigations to issues not relevant to assigned studies.
• Use appropriate project planning tools to communicate milestones and critical path activities and responsibilities.
• Work to optimize production schedules, balancing the customer requirements with best use of available capacity.
• Monitor and drive client specific, program-related gross margins and immediately report any deviation from projected targets.
• Lead the regularly scheduled program communication to leadership team.
• Facilitate team decision-making, identify, and escalate issues, when appropriate.
• Identify program expansion opportunities within existing client partnerships.
  
  

Competencies:

• Ability to build customer commitment and support operational excellence
• Natural ability to focus on priorities
• Instinctive team player who is used to collaboration and accountability (90/10)
• Ability to work collaboratively and motivate others to action
• Emphasis on business growth
• Knowledge in Project management with strong supply chain / operations sense
• Creative & innovative thinker
• Excellent interpersonal skills (at all levels)
• Reliability & dependability with the ability to meet deadlines consistently and manage multiple projects simultaneously
• Focused on continuous personal and professional development
• Effective at problem solving and decision making, decisive
• Excellent safety awareness
• Results driven, high attention to detail and process-oriented
• Excellent problem-solving & team building skills, comfortable managing ambiguity
• Strong business acumen, communication, and presentations skills
• Ability to work independently and as an active member and leader of a team is essential
• Ability to address delicate situations and effectively manage conflict to maximize project team progress
  
  

Qualifications And Education Requirements

• Accredited college, university or recognized professional degree (preferably advanced), in a life sciences field
• 1 years of hands-on experience managing programs and/or projects in advance (cell and gene) therapies preferred as an Associate Project Manager / Project Manager or equivalent
• Experience managing projects related to the support of clinical trials or commercial programs
• 1 years’ experience in a client-facing role in the pharma, biotech, or medical device industries
• Relevant experience of clinical trial import, packaging, storage, and logistics - preferably to include handling complex protocols, key clients, and business objectives
• Understanding of logistical requirements for different countries - ideal
• Understanding of GMP / GXP requirements
• Proficient in Microsoft Project, Word, Excel, and PowerPoint
• Excellent communication (verbal and written), organizational, and project co-ordination skills
• Flexible and adaptable with strong customer management and relationship building skills
• Able to analyze problems and define solutions
• Able to work under pressure and to support others within a team

Preferred Qualifications

• Proficiency in project planning tools e.g., Celoxis / MS Project to communicate milestones and critical path activities and responsibilities.
• Good working knowledge and experience using Lean and 6-sigma tools.
  
  

Compensation:

up to $75K commensurate with experience

Cryoport Systems is an Equal Opportunity Employer offering competitive compensation with a generous benefits package that includes health insurance, a 401K with company match and stock equity (Nasdaq: CYRX).



To learn more about Cryoport Systems, please visit



https://www.cryoport.com/