Operations Manager-USA

About the role

Cryoport Systems is a comprehensive supply chain partner for the life sciences industry, delivering specialized solutions to meet the challenges of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health markets. 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.

Responsibilities

• Lead and direct the safety and quality of daily operations
• Oversee all tasks on the floor including Inventory System operations; aid and troubleshoot discrepancies when required
• Coordinate with program managers, customer service, and logistic center to ensure on-time delivery of project work and deadlines
• 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 for completeness and accuracy
• Demonstrate solid technical writing abilities and 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 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
• Lead, participate, and contribute to operational excellence and process improvement projects
• Supervise temporary contract staff as required
• Participate in client audits, facility presentations and tours as needed
• Perform project/task-specific training as required

Qualifications

• Degree level, or equivalent experience, in a relevant discipline
• Minimum 4 years' experience working in a GMP / GxP environment
• Minimum of 1 year's Management experience preferred
• 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 in computer skills, specifically with Microsoft Office Suite
• Health, Safety, and Environmental knowledge is desirable
• Experience working in a contract development or manufacturing environment is a plus

Skills

• Exhibit appropriate behavior, language, and appearance always
• Follows policy when escorting client sponsors through the facility, is courteous, and displays a positive attitude
• Maintains a professional manner when problems/conflicts arise
• Good understanding of quality management
• Flexible and adaptable with excellent interpersonal skills
• Able to analyze problems and define solutions
• Attention to detail - "right first time" mentality
• Able to work under pressure and to support others within the team
• Builds customer commitment
• Supports operational excellence
• Teamwork, collaboration, and accountability
• Emphasis on business growth
• Passion for and alignment with, Cryoport's mission
• Exceptional and dynamic communications skills
• Exceptional organizational and planning skills, strong analytical abilities, and process orientation

Other Information

This position is subject to pre-employment drug testing in accordance with our commitment to maintaining a safe and drug-free workplace.