Operations Manager-USA

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. Our offerings span logistics, BioServices and biostorage, cryopreservation, and consulting, ensuring the highest standards of quality and reliability for sensitive materials. With our expansive platform of management solutions and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ by supporting certainty and precision in the supply chain, whether advancing groundbreaking therapies, supporting families on their reproductive journeys, or enhancing animal health programs.

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 involves 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 and 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; 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.
• Will 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 completeness and accuracy. Ensures all job-related paperwork is correct, error-free, and completed as 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.
• Assists 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.
• Ensures project work areas are kept clean and free of any possible safety hazards.
• Monitors the inventory management system, temperature monitoring, and site infrastructure systems.

• Works around hazardous substances and follows all safety guidelines to minimize exposure. •Assures compliance with cGMP requirements, safety, and company quality systems.
• Responsible for complying with all company and HR policies and procedures. •Will lead, participate, and contribute to operational excellence and process improvement projects that cost-effectively deliver the business objectives. •Will always ensure strict client confidentiality. •To participate and contribute to operational excellence and process improvement projects that cost-effectively deliver the business objectives. •Supervision of temporary contract staff as required. •To 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. •Other duties as assigned

COMPETENCIES & PERSONAL ATTRIBUTES

• 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.
• 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.
• Flexible and adaptable with excellent interpersonal skills (at all levels).
• 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 (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 EDUCATION REQUIREMENTS

• Degree level, or equivalent experience, in a relevant discipline.
• Minimum 4 years' experience working in a GMP / GxP environment.
• Minimum of 1 years' Managery 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.
• Willingness to function in an "on-call" rotation to support needs of business

DRUG TEST

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