Apheresis Operations Manager

Apheresis Operations Manager
Empresa:

Bristol-Myers Squibb


Apheresis Operations Manager

Detalles de la oferta

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Come join Celgene for this unique opportunity to be part of the team building a leading edge Clinical and Commercial CAR T Platform that serves our patients with novel Celgene CAR T Therapies.

The Manager Patient Operations Apheresis is accountable to manage onboarding and on-going performance of Apheresis Centers used for Celgene Clinical and Commercial Chimeric Antigen Receptor (CAR) T-cell Therapies. This role will serve as the technical operations single point of contact for Apheresis Centers located within the designated region of Europe and may require management of contract employees.

This role is regionally based out of home or at corporate office to service designated regions of Europe (Spain). Regional travel up to 60% of time may be required.
Responsibilities will include, but are not limited to the following:
Develop and foster relationships with Apheresis Center Staff for assigned region.
Work with Clinical and Commercial CAR-T teams to establish the apheresis collection footprint to support the clinical trial and commercial site plans for assigned region/country.
Coordinate with internal teams and collection site staff to ensure all collection site onboarding activities are successfully completed and sites are prepared to perform collections for Celgene within the required timelines.
Communicate collection site on-boarding status to Clinical and Commercial teams and develop and execute mitigation plans for any delayed timelines.
Perform technical site assessments and train collection center staff on Celgene collection requirements and attend site audits as required
Provide Quality Systems support by participating in deviation activities and impact/investigation assessments for cell collection centers.
Work with Quality Assurance and other internal business partners to monitor and assess vendor performance and capacity after site launch.
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.

Skill and Knowledge Requirements:
Ability to rapidly solve problems and deal with organizational complexity
Ability to prioritize and complete work with sense of urgency based on criticality
Medical, scientific and clinical knowledge
Knowledge of applicable regulations and standards
High attention to detail skills
High organization skills with ability to multi-task several tasks in parallel
Required Undergraduate Degree in Life Sciences or Engineering (Registered Nurse, Biomedical Engineer)
Required Minimum years of experience in a regulated environment either hospital or pharmaceutical/biotech
Required written and verbal fluency in English and Spanish language

Preferred but not required:
Advanced degree in the Life Sciences or Engineering (e.g. Pharm D, NP, PA, Biomedical Engineer)
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

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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