Apheresis Operations Manager

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Job Information
Bristol Myers Squibb
Apheresis Operations Manager
in
Rome
Italy
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.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
The Role
We are now looking for the Apheresis Operations Manager,
who will be 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 both field based or office based to service designated regions of Europe (Germany, UK, France, Italy, Spain, Switzerland, Austria, Belgium). Regional travel up to 75% of time within Europe may be required.
Key Duties And Responsibilities
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.
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.
Qualifications, Knowledge and Skills Required
Master's Degree in Life Sciences or Engineering
(Registered Nurse, Biomedical Engineer)
Minimum 4 years of experience
in a regulated environment either hospital or pharmaceutical/biotech
Required written and verbal fluency in English and Italian language
Customer focused relationship skills
Facilitation and Negotiation skills
People and project management skills
Demonstrated ability to work as part of a team
High level of interpersonal and communication skills (written and verbal)
Ability to work independently
Ability to manage consultants/contractors
Ability to rapidly solve problems and deal with organizational complexity
Ability to prioritize and complete work with sense of urgency based on criticality
Ability to interface cross-functionally both internally and externally
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
Proficient computer skills with Microsoft Word, Excel, PowerPoint
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
L'appartenenza alle categorie protette, lg. 68/99 costituirà titolo preferenziale .
What's important to us
Employees are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases:
Passion
: Our dedication to learning and excellence helps us to deliver exceptional results.
Innovation
: We pursue disruptive and bold solutions for patients.
Urgency
: We move together with speed and quality because patients are waiting.
Accountability
: We all own BMS' success and strive to be transparent and deliver on our commitments.
Integrity:
We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
Inclusion
: We embrace diversity and foster an environment where we can all work together at our full potential.
We have a passion for tackling the toughest diseases, which inspires innovation and speed in our daily work and a sense of accountability to the patients we serve.
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.
Company:****
Req Number:
R1526589_EN
Updated:
2020-07-27 00:00:00.000 UTC
Location:
Rome,Italy
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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