Sr. Manager Cell Therapy Operations

Sr. Manager Cell Therapy Operations

Are you ready to make a significant impact in the field of healthcare? As the Sr. Manager of Cell Therapy Operations, you will be at the forefront of developing processes and procedures to manage Apheresis Centers and Cell Therapy Centers! This role serves as the technical and operational single point of contact for these centers, ensuring the smooth running of AstraZeneca Clinical CAR T-cell Therapies.

Accountabilities:

The Sr.Manager of Cell Therapy Operations is responsible for developing the processes and procedures to onboard/manage Apheresis Centers and Cell Therapy Centers, the day-to-day scheduling/logistics/communication with those centers for AstraZeneca Clinical CAR T-cell Therapies.  This role will serve as the technical and operational single point of contact for Apheresis and Cell Therapy Centers.

Responsibilities will include, but are not limited to the following:

• Establish apheresis/cell therapy site qualification criteria, documents/process and then conduct technical site assessments and training for AstraZeneca clinical trials.

•  Create and maintain Apheresis and Product Administration manuals and forms that are product specific and consistent across all active trials

• Develop and foster relationships with apheresis/cell therapy site managers/staff for assigned region.

• Work with Clinical teams to establish the apheresis/cell therapy footprint to support the AstraZeneca clinical trials.

• Coordinate with internal teams and apheresis/cell therapy site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to support within the required timelines.

• Develop and build processes, SOPs, Wis, etc. to support the day-to-day operations of Clinical Trials

• Support the day-to-day operations (scheduling, communication, logistics, etc.) of Clinical Trials

• Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for apheresis/cell therapy centers.

• Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.

• Develop, maintain, and evaluate key performance indicators for patient treatment execution

• Manage rollout of process changes to assigned sites.

• Collect VOC (voice of customer) and VOB (voice of business) feedback used for continuous operations improvement.

• Collect and enter data into electronic data management systems.

• Represent the department on cross-functional project teams, as requested.

• Comply with applicable SOP’s and regulations.

Essential Skills/Experience:

• Ability to rapidly solve problems and deal with organizational complexity
• Ability to prioritize and complete work with a sense of urgency
• Medical, scientific and clinical knowledge
• Knowledge of applicable regulations and standards
• High attention to detail skills
• High organization skills with ability to multi-task
• Undergraduate Degree in Life Sciences or Engineering with 1+ years of experience in a similar role
• Experience in a regulated environment either hospital/clinic or pharmaceutical/biotech
• Experience in Cell Therapy Operations

Desirable Skills/Experience:

• Advanced degree in the Life Sciences or Engineering
• Experience working in Apheresis, Cellular Therapy or Stem Cell Transplant programs
• Prior customer facing role in pharmaceutical/biotech industry
• Experience working with critical raw material suppliers or contract manufacturing organizations

Why AstraZeneca:

At AstraZeneca, we are committed to getting more medicines to patients quickly, affordably, and sustainably. Our Operations team is at the heart of this mission, leveraging technology to create smart factories and transform our ways of working. We are a diverse, multigenerational workforce united by our curiosity. We share learnings, scale fast, and use data to improve our processes. Join us on this exciting journey as we accelerate our digital transformation, making a bigger impact on society, the planet, and our business.

Ready to make a difference? Apply today and play an integral part in delivering life-changing medicines!

The annual base salary (or hourly rate of compensation) for this position ranges from $ 128,631.20 - $192,946.80.However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.