Cellular Life Solutions Director
Blood Center Headquarters (La Concha)
Cellular Life Solutions Director
Hours Per Week:
8am to 5pm
Monday through Friday
GULF COAST REGIONAL BLOOD CENTER
Location: 1400 La Concha Lane in Houston, Texas 77054
TITLE/CODE: Director – Cellular Life Solutions
DEPARTMENT: Cellular Life Solutions
SCOPE OF RESPONSIBILITY
Reporting to the Chief Medical Officer, this position is responsible for effectively developing and managing all operational, quality management and business development aspects of cellular and gene therapy activities at The Blood Center. This includes operational and quality management of Cellular Life Solutions’ Medical Apheresis Center, which collects peripheral blood stem cells, as well as a variety of allogeneic and autologous cells for clinical treatment and research. Responsibilities include business development within the cell and gene therapy industry, including development of collection protocols and new client onboarding negotiations.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following; other duties may be assigned. Management retains the discretion to add to or change the duties of the position at any time.
- Develop and implement strategic goals and operations for Cellular Life Solutions’ products and services.
- Direct supervision of CLS and staff, and ensuring staff is properly trained to perform duties adequately and maintain staffing levels.
- Develop strategies to onboard, and maintain clients for cellular and gene therapy, including apheresis and other collections, and supervise operations, quality and compliance, as well as and business aspects, as necessary.
- Cultivate and maintain a high-profile relationship with NMDP, accrediting agencies and institutions and related professional organizations (such as AABB, America’s Blood Centers, American Society for Apheresis, Standards Coordinating Body, Blood Centers of America, Be The Match Biotherapies); including other state and regional Donor Centers, Blood Centers, academic and research hospitals, and laboratories within and outside our region.
- Position has authority over and responsibility for ensuring that the Quality Management Program for all CLS areas is effectively established and maintained according to FACT [Foundation for the Accreditation of Cellular Therapy], AABB, FDA, and NMDP standards.
- Serve as Study Coordinator or supervise Study Coordinator as appropriate, for IRB approved studies and protocols, maintain records and reporting as required, coordinate with clients and impacted departments to ensure regulatory compliance with clinical trial activities of The Blood Center and Cellular Life Solutions’ protocols including human subject protections requirements and training for staff.
- Present timely and accurate reports to Management Team that provides information regarding collections volumes, center capacity usage, new market activity & current status of relevant accounts, for administrative, quality, and financial purposes.
- Creatively collaborate and drive innovative projects with other blood center departments as new product line and service opportunities emerge.
- Enforce The Blood Center's policies regarding EEO/Affirmative Action and Safety/Health.
Must not pose a direct threat or significant risk of substantial harm to the safety or health of himself/herself or others. Must comply with all applicable safety rules and policies and be willing to report actual and potential safety violations to the appropriate supervisor or manager.
Must maintain regular and acceptable attendance at such level as is determined in The Blood Center’s sole discretion.
Full time: must be regularly available to work at least 8 hours per day, 40 hours per week, or such other days or hours per week as The Blood Center determines are necessary to meet business needs.
Overtime (applicable only to non-exempt positions)
Must be available and willing to work such overtime per day or per week as The Blood Center determines is necessary or desirable to meet business needs.
Weekend and Holidays
Must be available and willing to work such weekends and holidays as The Blood Center determines are necessary or desirable to meet its business needs.
Must regularly be able to work at offsite locations and transport self to same.
This position supervises Cellular Life Solutions staff Responsible for the overall direction of this unit and carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor's degree from an accredited college or university; business, medical science or related field is preferred, with a minimum of five years of previous job-related experience or training to include management experience in a regulated environment. Advanced degree or certification in business or medical/clinical field is desired.
CERTIFICATES, LICENSES, REGISTRATIONS
Valid Texas Driver’s License and acceptable driving record
Ability to read, analyze, and interpret professional journals, technical procedures, and government regulations. Ability to write standard operating procedures, educational materials, routine reports, and correspondence, independently. Ability to communicate effectively with the donors, patients, clients, laboratory/hospital staff, physicians, and other caregivers. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to clearly present information through the spoken word; influence or persuade others through oral presentation in a positive or negative circumstance and to listen well; write clearly and effectively present ideas to document activities and to read and interpret a variety of written material.
Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables. Ability to make decisions quickly on available information and to take action; to make commitments and not change decisions when challenged and to deal with emergencies when necessary; to take action in solving problems while exhibiting judgement and a realistic understanding of issues; use reason, even when dealing with emotional problems.
GOAL SETTING/PROBLEM SOLVING SKILLS
Ability to define realistic, specific goals and objectives and to prioritize objectives; start and persist with specific courses of action while exhibiting high motivation and a sense of urgency; use a systematic approach in solving problems through analysis of the problem and evaluation of alternative solutions.
Ability to develop unique and novel solutions to problems; use intuition and a new way of thinking to create new ideas; present information in an attention getting and interesting manner.
Ability to work with people in such a manner as to build high morale and group commitments to goals and objectives; create positive energy (motivation) in both individuals and groups; communicate with others in a warm and helpful manner while simultaneously building credibility and rapport; influence the actions and opinions of others in a desired direction; exhibit judgment in leading others to worthwhile objectives.
OTHER SKILLS AND ABILITIES
Computer literate: Microsoft Office; must be able to become proficient on any specialized software within a reasonable period.
POSITION DRIVING STATUS
Personal Vehicle Driver (formerly Select Non-Consultant)
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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently required to operate a computer and other office machinery and remain in a stationary position. The employee must frequently lift and/or move up to 10 pounds. Employees are required to be familiar with and abide by the team lift requirements as specified in the Safety Program. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to blood and blood components as well as other biohazardous materials and outside weather conditions. The noise level in the work environment is usually moderate.
The Blood Center is an Affirmative Action/Equal Employment Opportunity Employer. Qualified applicants for positions are considered without regard to race/ethnicity, color, religion, national origin, age, pregnancy, sex, sexual orientation, gender identi t y, transgender status, military status, protected veteran status, disability status, genetic testing results or any other basis or characteristic prohibited by applicable law, statute, regulation or Executive Order.