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 Senior 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 (Germany, UK, France, Italy, Spain, Switzerland, Austria, Belgium).
Regional travel up to 75% of time within Europe 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.
? 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:
? 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
Qualifications and Experience Requirements:
? Required Undergraduate Degree in Life Sciences or Engineering (Registered Nurse, Biomedical Engineer)
? Required Minimum 4 years of experience in a regulated environment either hospital or pharmaceutical/biotech
? Required written and verbal fluency in English language and in the designated country language (Italian)
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