Overview

Work at ROCKET PHARMA and help cure rare diseases!

Rocket Pharma is a fully integrated, clinical-stage company advancing gene therapies with curative potential for multiple rare childhood diseases. Rocket places enormous value on people and considers team member progress and well-being to be as important as the progress of its pipeline. We are looking for hands-on team players who enjoy collaborating with colleagues. We share a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. This is an opportunity to become an integral part of a small, highly productive team and to help grow an entrepreneurial, scientifically driven organization that is increasingly recognized as a leading biotechnology innovator. In addition to a competitive compensation package featuring a generous 401K match and stock options, the position includes excellent health benefits.

Position Summary

We are seeking a Senior Manager, Apheresis Operations, to join the fast-growing supply chain team. We are seeking a qualified individual who is experienced in Leukapheresis operations (Aph Ops.) in the ex-vivo gene therapy space. The focus of this position is to provide technical and educational support to Qualified Treatment Centers (QTCs) with the apheresis process required as part of the Rocket gene therapy programs. The Senior Manager, Apheresis Operations may spend up to 50% of time providing support to QTCs for both the activation phase (including initial qualification and training) and the execution of the apheresis process required for Rocket gene therapy (including education on optimal cell collection, shipping of HPC-A, receipt and handling of drug product, and the infusion process). The ideal candidate has in-depth knowledge of the collection, processing, and storage of cellular materials, maintaining compliance with cGMP standards, and leveraging industry best practices. Ultimately, this role is tasked with implementing efficient and scalable apheresis processes to meet the demands of gene therapy manufacturing, focusing on quality, yield, and cost-effectiveness.

Responsibilities

• Support evaluation of treatment centers as part of QTC onboarding and activation to confirm whether the QTC has the capability to:
  • Conduct activities associated with the requirements of the Apheresis & Infusion manuals and the drug product handling guidelines.
  • Comply with standards established by the QTC and all applicable regulatory and licensing bodies (including, JACIE, local country regulations etc).
• Collaborate with the QTCs and supply chain to lead or co-lead QTC activities related to apheresis, shipment, drug product handling, and infusion.
• Provide on-site and/or remote training, oversight, and direction to facilitate the QTC in complying with the requirements of the Apheresis & Infusion manuals and the drug product handling guidelines.
• During coverage of collection and infusion procedures, serve as a liaison between the QTC staff (Apheresis, Analytical Laboratory, and Transplant Unit) and the Rocket commercial manufacturing and supply chain operations.
• Provide on-site/remote support to QTC staff as needed to optimize collection and infusion activities. (Note: this activity could require being in the same room as the patient but there must not and will not be any interactions with the patient. This may require coordinating travel to coincide with the patient visits.)
• Create, administer, and update the Apheresis manual and any other standards and procedures associated with cell collection, including cryopreservation and labeling as necessary.
• Assist with response, mitigation, and escalation of identified or potential issues at or related to QTCs, with robust follow-up on issues and support for QTC improvement efforts.
• Serve as a key member of the Rocket cross-functional team to provide continuous feedback on QTC performance regarding the apheresis and infusion process required for the Rocket gene therapy programs.
• Provide feedback and recommendations to the QTC for the apheresis & infusion process, improvements and documents, manuals, guides, and work instructions to optimize compliance with the Apheresis & Infusion manuals and the drug product handling guidelines.
• Foster positive collaborative relationships with assigned QTCs.
• Support systems and teams at the QTC in the optimization of collection procedures, efficiency, and quality.
• Actively engages in the identification, sharing, and adaptation of best practices with QTCs.
• Work closely with the Rocket Commercial Manufacturing and Supply Chain function to ensure the traceability of patient cell collection and drug product infusion through the patient treatment pathway.
• Provide Quality Systems support through the management of deviations associated with QTC including but not limited to opening and owning a deviation, conducting investigation and impact assessments, and defining and implementing CAPA.
• The responsibility scope is subject to adjustment based on the specific business needs and priorities of the organization.

Qualifications

• Bachelor's degree in the life sciences field with 10 years of experience in a regulated environment either hospital or pharmaceuticals/biotech or apheresis and/or cell therapy operations management
• Experience working in Cell Therapy, Apheresis, or Stem Cell Transplant programs is essential.
• Experience working in a regulated environment (cGMP/GCP/GTP) preferred
• Experience with FACT/ JACIE and ISBT accreditation procedures
• Infusion therapy, involving complex therapies
• Understanding the underlying medical principles of gene therapy and apheresis procedures is essential. This includes knowledge of the patient's condition, the therapeutic target, etc
• Experience with clinical trials, research activities, or commercial cell & gene therapies
• Effective training and presentation skills
• Must be willing to travel up to 70-80%; may include weekend travel
• Ability to be flexible in a fast-paced environment
• Ability to work independently with very limited supervision
• Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality, and risk.
• Effective teaching, training, planning and problem-solving ability
• Detail-oriented and able to assess and assimilate data and communicate objectively
• Excellent collaboration skills; establish good relationships with QTC staff and internal teams
• Competent computer skills (MS office, Cloud-based programs, Quality Management Systems)
• Strong verbal and written skills; ability to provide focus and clarity; able to handle confidential information and material appropriately

Travel Requirement: 50%

EEO Statement

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.