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Manager Cell Collection and RP

Auris Health

Auris Health

Belgium
Posted on Tuesday, August 29, 2023
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Description

The Manager Cell Collection and Responsible Person is responsible for shaping and managing the operations and processes for the supplier network of apheresis and cryopreservation for commercial CAR-T starting materials. The successful candidate is able to create essential infrastructure with the Global Cell Collection & Delivery team to further build towards a fully operational and reliable supplier network. Effective liaising with key internal and external stakeholders is key to shape and improve processes and systems to support this. Leading site certifications and tech transfer activities for both hospitals and large, centralized cell processing labs are an integral part of the job.
This key role will also lead all aspects related to standards and regulatory requirements to start up and maintain a central cryopreservation facility as Tissue Establishment. Consequently, the successful candidate is able to appropriately balance fit-for-purpose requirements with vein-to-vein time and costs. Up-to-date hands-on knowledge of industry standards and regulatory requirements related to cellular therapies are critical. This comprehensive role is formally accountable for our cryopreservation facility as Responsible Person (RP) and will serve as the single point of contact for the Belgium
inspectorate. The RP will need to be prepared upon short notice to communicate with the Belgium Inspectorate as well as with site physicians on compliance and apheresis starting materials, respectively.
Given the central role in the organization, colleagues that able to naturally foster strong partnerships with other groups are most influential, e.g. in reducing our supply base and achieve operational excellence goals.
 
Responsibilities:
- Builds, shapes and maintains Global Cell Collection network to ensure reliable, available and cost-effective operations supporting our patients
- Facilitates and conducts technology transfers and training for sites within EMEA, shaping the EMEA network
- Refines and executes site selection, qualification, and onboarding activities
- Has in-depth knowledge of apheresis, cellular processing, and medical know-how
- Executes issues management, risk management and change management
- Builds and shapes infrastructure and capabilities to regionally support commercial activities (internal and external)
- Responsible Person for Tissue Establishment (‘intermediate structure’) under Belgium law (wet MLM)
- Accountable for successful inspection by Belgium authorities
- Acts as primary point of contact for FAGG
- Drives issues management and risk management

Qualifications

- A Medical Degree (MD) with clinical experience in hematology and/or cellular therapies
- Hospital and specifically tissue establishment or cell bank experience required
- A minimum of 5 years of experience in a pharma, hospital or blood bank environment is required
- In depth knowledge of cGMP and the EU Tissue and Cell Directives is required, as well as knowledge of the applicable Belgium laws (such as wet MLM) or the willingness to learn quickly
- Fully proficient in the European Regulations and Directives, supplemented with knowledge of the JACIE standards and licensing requirements
- Ability to effectively work in multinational teams and enjoys a multicultural environment
- Project Management skills and the ability to interface cross-functionally with clinical and manufacturing personnel is required
- Understanding of drug development and submission requirements is preferred
- Manufacturing and logistics understanding/experience is preferred
- Experience working independently and in a matrixed team environment is required
- Has demonstrated to be able to make decisions independently; an innovative and strategic thinker with broad vision is key for this job
- Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required
- Ability to communicate clearly and effectively with all levels of the organization
- Ability to summarize and present results, and experience with team-based collaborations is a must
- Ability to manage an ambiguous environment and work with a sense of urgency
- In addition to fluent English, able to read, write and speak one additional European language
- Travel may be required up to 10% of time
- Eligible to work in Belgium