Manager, Cellular Therapy - Stem Cell Program

Job Description:

Job Summary

Plan, organize, directed, and evaluate either Quality Control, Cellular Therapy Laboratory, or Manufacturing Science and Technology (MSAT) activities. Manage product and project deliverables to ensure the safety and reliability of products produced are in compliance with quality and regulatory requirements. Manage administrative duties which include daily technical oversight of the laboratory and the completion and reporting of test results. Interview and evaluate candidates to fill vacancies. Oversee the training, retraining, and competency assessment of personnel. Provide support, development, and/or technical resource to internal or external customers. Maintain knowledge of and perform duties in compliance with regulations outlined in the applicable Code of Federal Regulations (CFR) and other industry standards (such as the Foundation for the Accreditation of Cellular Therapy (FACT) and the American Association of Blood Banking (AABB).

Salt Lake, UT is the primary location, and Portland OR is the secondary location preferred. If living outside these areas must be willing to travel.

Responsibilities

• Oversee the daily operations of Quality Control, Cellular Therapy, or MSAT within the laboratory setting.
• Participate in budget planning and cost-effective analysis, whenever necessary.
• Manage staff including, but not limited to scheduling, training, coaching, and performance evaluations.
• Manage the discipline, transfer, and charge of staff and the interviewing and evaluation of candidates.
• Coordinate periodic laboratory proficiency testing and reporting. May perform testing as appropriate.
• If managing quality control activities, collaborate with manufacturing, technical, and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
• Communicate and collaborate with internal customers in other departments and regions regarding testing schedules, coordination of the receipt of test results, and hand-offs to improve quality and efficiency. May compile and report monthly testing statistics.
• If managing Cellular Therapy/MSAT activities, oversee the achievement of organizational and daily production goals and ensure the timely and accurate completion of products to clients.
• Review and interpret final results; prepare and review final reports, written or electronic.
• Oversee the operation and maintenance of all laboratory equipment and software.
• Communicate with vendors and perform equipment service or troubleshooting, when needed. Oversee the implementation of process, product and equipment changes and upgrades according to the established change control plan.
• Ensure applicable daily/weekly/monthly/yearly quality controls for reagents, supplies, and equipment are performed and reviewed timely.
• Evaluate, prepare, validate and implement new laboratory techniques. Manage compliance, quality improvement activities, and inspection management. Monitor discrepancy occurrences and resolutions to assure appropriate decisions, product dispositions, and documentation of problems. Assure records are reviewed, managed, and archived according to requirements. Maintain an orderly workspace.

Qualifications

• Bachelor's degree in biological science or chemistry.
• Medical Laboratory software (MLS), Medical Technologist (MT), Clinical Laboratory Scientist (CLS) or equivalent certification.
• Licensure if required by the state.
• Minimum 5 years of experience in clinical testing and cellular therapy, with 3 years in an accredited laboratory.
• Minimum 3 years of experience supervising a clinical laboratory.
• Prior experience in budget planning and administration of a high-complexity testing laboratory preferred.
• Strong written and verbal communication skills.
• Proven organizational skills with the ability to prioritize tasks, delegate and follow up.
• Strong interpersonal skills. Ability to work on a team and independently.
• Ability to provide training and guidance to laboratory staff.
• Ability to guide, supervise and motivate staff to achieve laboratory goals.
• Ability to delegate laboratory tasks or assignments to staff appropriately and effectively.
• Ability to resolve complex technical and personnel problems, often involving large groups of people.
• Comprehensive knowledge of Quality Control, Cellular Therapy and MSAT programs, workflow and organization.
• Comprehensive knowledge of regulatory issues related to laboratory work performance.
• Ability to develop cost analysis and monitor expenses to conserve resources. Ability to work on a team.
• May involve variable locations and some travel.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. You must be able to stand for long periods of time, repeat the same movements, and use your hands to handle, control, or feel objects, tools, or controls. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. This job requires the ability to hear and speak clearly. The employee must frequently lift and/or move up to 15 pounds and occasionally lift and/or move up to 30 pounds. The work environment will consist of moderate noise. The employee must be able to react quickly using hands, fingers, or feet. This job may require the employee to be able to bend, stretch, twist, or reach out. This position will require the ability to use the stomach and lower back muscles to support the body for long periods of time and the ability to keep or regain the body's balance or stay upright when in an unstable position. Employees must be able to frequently use one or two hands to grasp, move or assemble objects. The employee must have the ability to work in a small cubicle and have the ability to sit at a computer terminal for an extended period of time.

The American Red Cross requires all new hires to be vaccinated against COVID-19 as a condition of employment. This means that all individuals working for the organization must be fully vaccinated against COVID-19 by the start of their employment OR have begun the vaccination process before their start date. Upon being offered a position, individuals will be required to submit proof of vaccination. If you are unable to be vaccinated due to medical or religious reasons, you may qualify for an exemption. If seeking an exemption, you will be required to submit documentation and your request must be approved before being hired.

As part of the world's largest humanitarian network, the American Red Cross places top priority on the health and safety of our employees, volunteers, blood donors, and those who receive our aid and services. Our commitment to public health is unwavering-both during the COVID-19 pandemic and year-round.

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The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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Visit redcross.org/volunteertoday to learn more, including our most-needed volunteer positions.

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