Operations Specialist - Apheresis Procedure and Equipment - Remote

Please apply online using a laptop or desktop computer. POSITION SUMMARY : This position provides Subject Matter Expertise and consultation to NMDP-BioTherapies and clients related to Operations activities.

As part of the operations teamwork will include the development of new processes and / or services as needed.

You will develop training, coordinate, and support centers to collect products both in commercial and clinical trial settings.

In this role, you will manage NMDP-BioTherapies Collection Network center operations supporting qualified key staff including clinical trial staff as well as apheresis unit and cell laboratory staff.

Ensuring that the centers are operating to safely and efficiently collect and process starting material and supporting continuous operations improvements.

This is a remote position (US).

LI-Remote Check out our video Saving Lives : It's the Best Job Ever ACCOUNTABILITIES : Site Management :

• Manages BioTherapies Collection Network (BCN) contracting processes for Client protocols.
• Provide highly engaged site operations support to staff from initial contracting through protocol operationalization.

Site support includes continued training based upon NMDP-BioTherapies and client specifications, ensuring that centers meet critical accountabilities, milestones, and deliverables.

• Conduct investigations in partnership with the quality team / department through assigned deviations related to incoming specifications, chain of identity breaches, and other related deviations of client specification as well as investigating manufacturing results when requested.
• Oversee the end-to-end process of deviations in close coordination with all relevant functions to ensure closure of deviation.
• Receives, reviews and processes NMDP-Biotherapies network center key performance indicator (KPI).
• Coordinates audits and qualification of BCN centers with BTMB Quality team.
• Identifies operational inefficiencies in Collection Center operations.
• Proposes and implements solutions in consultation with department leadership. Technical Subject Matter Expert :
• Develop and maintain knowledge of the customer, key dynamics, and company policies as well as up to date knowledge of key competitors and their strategies.
• Serves as advocate for NMDP-BioTherapies network centers to ensure that NMDP-BioTherapies product collection and quality management needs are assessed and appropriately addressed.
• Participates as an apheresis and cellular therapy process SME on project teams related to NMDP-BioTherapies products.
• Participate and support client audits as required.
• Provide technical expertise and consultation to NMDP-BioTherapies network centers, NMDP-BioTherapies stakeholders, clients, and other departments as required.
• Provides advice and guidance to NMDP-Biotherapies stakeholders, clients, and network centers in the collection and processing of NMDP-Biotherapies products.
• Provides Supervisor with an individual assessment of Client Intake Form and / or Proposal, as requested.
• Is qualified and trained as a Change Control Champion, assisting the operations team with any change control needs.
• Participate and support client audits as requested.
• Serve as the CAPA designee for all quality issues assigned to the operations team to maintain quality system compliance, as available.

Site Onboarding and Training Support :

• Identify and qualify Network Centers for participation in client / sponsor directed work for allo, auto, and matched allo clinical trials.
• Create and maintain Project riders for client / sponsor directed work performed at BioTherapies Collection Network Centers.
• Works in partnership with Education & Training staff to deliver learning experiences to the NMDP and NMDP- Biotherapies network partners when technical expertise is integral to the content.
• Drive completion, adherence to training requirements and assess appropriate level of training for team members, completes their training plan on time and ensures proficiency and qualification to perform the production tasks.

Monitors team training due dates and maintains the trained status of all team members by ensuring appropriate time is allocated to training activities.

• Monitors and surveils comprehensive KPI data (all product types) to identify common issues, best practices, and recommend and assist in the development of standardized protocols.
• Serve as the initial point of issue escalation for the Cell and Gene Therapy Specialists on issues with processes, clients, or suppliers.
• Acts in the Resolver role for the Occurrence database.
• Monitors and reports out to NMDP-Biotherapies stakeholders of any occurrence trends that are noted quarterly. Training Support :
• Assists with the development and maintenance of training materials for onboarding.
• Serve as a leader for team members onboarding and training. Other Accountabilities :
• Participates as a subject matter expert in additional projects and duties as assigned.
• Acts as a role model supporting the strategic goals and initiatives of the NMDP- BioTherapies.
• Adheres to NMDP's confidentiality policies for the patient, donor, and proprietary NMDP information.
• Performs all duties in compliance with standard operating procedures, National Marrow Donor Program (NMDP) standards, and regulations outlined in the Code of Federal Regulations (CFR), Federal Drug Administration (FDA) regulations, guidance, and other applicable Federal, state, and local laws.

Adheres to OSHA guidelines as applicable.

• Other duties as assigned. REQUIRED QUALIFICATIONS : Knowledge of :
• Technical knowledge of apheresis procedure and equipment.
• Technical knowledge of cell therapy lab processing and advanced testing
• Basic knowledge of quality and regulatory requirements for pharmaceutical, biologic, or medical devices preferred, including Good Manufacturing Practices (GMP), Good Tissue Practices (GTP), and Good Documentation Practices (GDP).
• Knowledge of quality management principles and understanding of biological product manufacturing processes are preferred. Ability to :
• Demonstrate strong attention to detail and excellent organizational skills.
• Think analytically and critically; communicate effectively both verbally and in writing.
• Demonstrate complex problem-solving skills.
• Demonstrate advanced communication skills including writing and oral abilities to connect with a wide range of people to discuss sensitive information.
• Exhibit strong customer service skills and ability to apply concepts of active listening and empathy. Education and / or Experience :
• Bachelor's degree in health or biological sciences, medical technology, nursing, or other science-related field preferred.

However, upon evaluation, equivalent experience, or related education in addition to the required experience may be substituted for the specific degree requirements.

Four years of healthcare experience within a healthcare setting.

cell therapy lab, apheresis, or hospital.

Experience within a blood center, apheresis center, or cell therapy lab setting is highly desired.

Experience working in a regulated environment including a demonstrated knowledge of Good Tissue Practices (GTP) and Good Manufacturing Practices (GMP) preferred.

• Experience providing in person or online training and remote support for clinical staff. PREFERRED QUALIFICATIONS : (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)
• Lean Six Sigma certification
• AABB CABP
• US / EU / HC Regulatory Experience DEI COMMITMENT : As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP.

We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender.

Everyone is welcome and supported in their development at all stages in their journey with us. BENEFITS : NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident / critical illness / hospital, well-being, legal, identity theft and pet benefits.

Retirement, paid time off / holidays, leave and incentive plans are also offered to eligible employees.

Please reference this link for more information : NMDP Benefit Information