Operations 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 Operations Manager - BioServices role ensures all operational activities are executed accurately and timely, following specific procedures and processes defined in work instructions created by Program Managers. The responsibilities of the Operations Manager – BioServices involve overseeing all projects performed in the BioServices area for multiple commercial and government clients and assembling various types of kits and label printing. These materials are stored at ambient (room) temperature to below freezing (including cryogenic) with potentially hazardous properties. This role will also require communicating with Program Managers, scheduling work, supervising staff, writing and updating SOPs and other project-related activities.

Primary Responsibilities include, but are not limited to:

• Lead and direct the safety and quality of daily operations
• Oversee all tasks on the floor including Inventory System operations; aiding and troubleshooting discrepancies when required
• Coordinate with Program Managers, Customer Service, and Logistics Center to ensure on-time delivery of project work and deadlines
• Effectively communicate to ensure all project related information is conveyed in a timely and comprehensive manner
• Ensure all activities follow health, safety, and environmental statutory, regulatory, and company regulations
• Assure the on-time completion of document review (batch records, receipts, shipment orders, daily routine tasks, inspections, and logbooks) for completion and accuracy
• Ensure all job-related paperwork is correct, error-free, and completed per SOPs
• Demonstrate solid technical writing abilities; develop, revise, and assist in writing SOPs, Work
  Instructions, Deviation Investigations, and Change Controls
• Maintain and ensure the team remains current on safety, quality, and GMP training
• Perform administrative tasks including (but not limited to) scheduling and assigning duties, on -call monitoring, attendance, disciplinary action management, planning and time off scheduling, hiring, and payroll
• Assist with Quality Control tasks such as verification, validation and calibration procedures
  as required
• Coordinate stock management and receipt of kit production, packaging, and labeling
  materials
• Manage stock levels of kit materials, packaging, and labeling components
• Ensure project work areas are kept clean and free of any possible safety hazards.
• Monitor the inventory management system, temperature monitoring, and site
  infrastructure systems.
• Work around hazardous substances and follow all safety guidelines to minimize exposure
• Assure compliance with cGMP requirements, safety, and company quality systems.
• Comply with all company and HR policies and procedures
• Lead, participate, and contribute to operational excellence and process improvement
  projects that cost-effectively deliver the business objectives
• Always ensure strict client confidentiality
• Participate and contribute to operational excellence and process improvement
  projects that cost-effectively deliver the business objectives
• Supervise temporary contract staff as required
• Participate in client audits, facility presentations and tours, as needed
• Perform project/task-specific training as required
• May be assigned as the Designated Representative for their location for state licensing for
  commercial drug distribution
• Fulfill other duties as assigned
   

Competencies & Personal Attributes

• Hands-on experience working with biological and pharmaceutical materials is desirable
• Hands-on experience working in clinical packaging and labeling is desirable
• Good understanding of quality management
• Previous experience working with materials at ultra-low & cryogenic temperatures is
  desirable
• Health, Safety and Environmental experience/qualification is desirable
• Ability to analyze problems and define solutions
• Attention to detail with a “right first time” mentality
• Able to work under pressure and support others within the team
• Builds customer commitment
• Exhibits appropriate behavior, language, and appearance at all times
• Flexible and adaptable with excellent interpersonal skills (at all levels)
• Follow policy when escorting client sponsors through the facility with courteousness and a positive attitude
• Maintain a professional manner when problems/conflicts arise
• Supports operational excellence (30/30)
• Focus on priorities (80/20)
• Teamwork, collaboration, and accountability (90/10)
• Emphasis on business growth
• Passion for and alignment with, Cryoport’s mission
• A change agent and strong collaborator who is not afraid of challenging the status quo
• An individual who brings strong core values, quality, ethics, and integrity
• A collaborative team player who embraces and champions the culture
• Strong work ethic and ability to deliver results and meet commitments in a dynamic
  environment
• Exceptional and dynamic communications skills with the ability to inspire and influence people at all levels, build consensus and commitment, and effectively drive change throughout the organization at a rate that fits the corporate culture
• Exceptional organizational and planning skills, strong analytical abilities, and process orientation
• Demonstrates a business process orientation to developing solutions

Qualifications and Educational Requirements:

• Degree level, or equivalent experience, in a relevant discipline
• Minimum 4 years’ experience working in a GMP / GxP environment.
• Minimum of 1 years’ managerial experience
• Hands-on experience working with biological and pharmaceutical materials and drug products
• Hands-on experience working in clinical packaging and labeling is desirable
• Line management experience is desirable
• Proficient computer skills, specifically Microsoft Office Suite
• Health, Safety, and Environmental knowledge is desirable
• Experience working in a contract development or manufacturing environment is a plus
• Willingness to function in on-call rotation to support the needs of the business

Compensation: $90K, 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/