Operations Technician - Bioservices

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 Technician - Bioservices will report to an Operations Supervisor or Manager,

this role is responsible for ensuring all operational activities are executed accurately and timely,

following specific procedures and processes as defined in Work Instructions. This Operations

Technician role involves the receipt, inventory, storage, withdrawal, packaging, labeling, and

shipment of biological materials, therapeutic products, clinical agents, and materials from

multiple commercial and government clients. This position may also participate in the assembly

of various types of kits and label printing, involving materials stored at temperatures ranging

from ambient (room temperature) to below freezing (including cryogenic) with potentially

hazardous properties.

PRIMARY RESPONSIBILITIES (include but are not limited to):

• To perform receipt and inventory management of biological materials (including

therapeutic drug products), data entry, relocation, retrieval, packaging, and logistics

operations according to standard operating procedures.

• To undertake packaging and labeling of pharmaceutical product at all temperatures

(including low and ultra-low temperatures) according to standard operating procedures

• Assemble a range of kit types according to strictly defined client specifications.

• Liaising with Program Managers to provide support with the scheduling of work, assisting

in writing and updating SOPs, and other project-related activities.

• To assist in deviation investigations and change control documentation.

• Scheduling of project work, accounting for deadlines, available resources, and business

need.

• Disseminating information from and providing feedback to Project Managers.

• Coordinate stock management and receipt of kit production, packaging, and labeling

materials.

• Manage stock levels of kit materials, packaging, and labeling components.

• Assists with Quality Control tasks such as verification, validation and calibration

procedures as required.

• Ensures project work areas are kept clean and free of any possible safety hazards.

• Understands and uses the inventory management, temperature monitoring,

and site infrastructure systems.

• Primary responder to all equipment alarms and an active member of the site "On-

Call" team - responding to all alarms, including out-of-hours (24/7 on a rotating cycle

with other team members)

• To be available for infrequent overtime work as necessary and to be willing to attend

site, out of hours in the case of emergency or extraordinary work requirement.

• Documents alarms in response to the temperature monitoring systems.

• Works around hazardous substances and follows all safety guidelines to minimize

exposure.

• Assures compliance to cGMP requirements and company quality systems.

• Maintains cGMP training records and participates in staff quality training

• Ensures all job-related paperwork is correct, error-free, and completed in real-time as per

• Ensures strict client confidentiality at all times.

• To participate and contribute to operational excellence and process improvement

projects that cost-effectively deliver the business objectives.

• Assist in the supervision of temporary contract staff as required.

• To participate in client audits and facility presentations as needed.

• To effectively communicate to ensure all project related information is conveyed in a

timely and comprehensive manner.

• Perform project/task-specific training as required.

COMPETENCIES & PERSONAL ATTRIBUTES

• Exhibit professional behavior, language, and appearance at all times.

• 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.

• 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 is preferred.

• Minimum 1-2 years experience working in a GMP / GxP environment.

• Hands-on experience working with biological and pharmaceutical materials and drug

product.

• Hands-on experience working in clinical packaging and labeling is desirable.

• Line management experience is preferred.

• Proficient in computer skills, specifically with Microsoft Office Suite.

• Experience of working in a GMP environment.

• Health, Safety, and Environmental knowledge is desirable.

• Experience working in a contract development or manufacturing environment is a plus.

• Frequently required to type, sit, stand, walk, lift/carry up to 55lbs. Occasionally

required to push/roll 280kg lb. liquid nitrogen dewars and 4-500kg freezers (with

support) and work from a platform ladder.