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Job Details

Apheresis Operations Investigator

Company: Novartis
Location: United Kingdom Frimley / Camberley
Reference: 236358BR
Closing Date: 19 Jun 18
Type: Full Time
Salary (£): On Application

Job Summary:

Apheresis Operations Investigator, Novartis, UKJob Summary:Would you like to work for a Global Pharmaceutical company and contribute to our mission to extend and improve people’s lives? Look no further, apply today. Apheresis Operations Investigator, Novartis, England. ...


Apheresis Operations Investigator, Novartis, UK

Job Summary:

Would you like to work for a Global Pharmaceutical company and contribute to our mission to extend and improve people’s lives?
Look no further, apply today. Apheresis Operations Investigator, Novartis, England.

Job purpose:

The Apheresis Operations Investigator is responsible for ensuring that issues related to cellular material received in Europe are appropriately evaluated, investigated, and have required feedback and follow-up with the sites providing the cells (i.e. apheresis sites). The position is responsible to manage simulated processing/mock shipments, and maintain KPI metrics on deviations to the site and network level.
Apheresis Operations Investigator will interface and collaborate closely with the Apheresis Operations Tissue Experts who interface directly with the hospital customers acting as cellular material suppliers.

Key Responsibilities:

Cellular Material Investigations

• Ensure that incoming cellular material have deviations assigned as coordinated with internal receiving and QA groups.
• Receive ownership of deviations, ensuring that immediate assessment and product impact assessment are completed to avoid manufacturing start delay in cases where there is no impact, ensuring that ensuring that clinical QA is appropriately involved when clinical Protocol Deviation may also have occurred.
• Lead Investigation to identity the root cause of Deviations, through direct investigation, and coordination of investigation actions with field force apheresis operations team working with hospital customer/suppliers, clinical operations, and other cross-functional organizations as needed.
• Ensure that appropriate CAPA are determined, accepted by QA, and assigned to the appropriate function.

Simulated Processing and Mock Shipment Management

• Working with Apheresis Operations Tissue Experts and project management, ensure that needed ‘mock shipments’ for sites are scheduled, and have healthy donor cellular material coordinated and scheduled as required.
• Ensure that mock shipment material is received per SOP, and ensure that the “feedback form” assessment has been completed.
• Evaluate mock shipment for success, and recommend appropriate feedback for the sites, coordinating with site-assigned field Apheresis Operations Tissue Experts.

Apheresis Operations Department

• Support implementation and maintenance of applicable SOPs.
• Ensure management is kept informed of all critical and major issues.
• Ensure coordinated contact and collaboration is maintained with other functions (e.g. QA, Clinical, Sourcing, Legal, Supply Chain, Regulatory, and Manufacturing & CMO-QA/ESO).
• Support maintenance of the Leukapheresis material requirements and Leukapheresis Manual(s).
• Support Novartis Third Party Approval process performing initial and updated SQRA and other approval documentation.
• Support site onboarding/readiness activities led by Apheresis Operations Tissue Experts.
• Support collection of KPI data related to deviations and deviation trends for the site network and for individual sites to facilitate operations performance reviews (i.e. collecting data on trends, KPI and coordinate trending with global apheresis to facilitate continuous improvement for sites and the network)
• Management of change control, coordinating with global and regulatory.
• Coordinate with field personnel on ongoing site needs

Position may require occasional travel externally.

About Novartis:

Our mission is to care and cure; We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life. We also want to provide a shareholder return that reflects outstanding performance and to adequately reward those who invest their money, their time and their ideas in our company.

Novartis Pharmaceuticals UK has been certified by the Top Employers Institute as “Top Employer Europe 2017”!

Novartis Oncology is committed to developing innovative cancer medicines and improving access to treatment through patient assistance and cancer resource programs. We are continually exploring new commercial and access models to best meet the needs of cancer patients and adapt to changing healthcare environments.

Benefits of Working for Novartis:

Competitive Salary
Annual Bonus
Strong Work/Life Balance, flexible working
Top UK Employer
Pension Scheme
Share Scheme
Paid holidays
Comprehensive Medical Insurance
Subsidised Canteen
Employee Recognition Scheme
Sports & Social Club

‘I came for the job, I stay for the culture’


Minimum requirements

The ideal candidate will have:

• Education: University degree with an advanced degree in science preferred
• Languages: English required
• Experience: 10+ years of GxP pharmaceutical experience or at least 5 years pharmaceutical experience and equivalent experience in blood and tissue operations
• Experienced working in a highly matrixed environment
• Track-record managing complex projects
• Knowledge in drug development
• Knowledge of European blood and tissue directives
• Clinical trial and manufacturing operations experience desirable
• Prior logistics / supply chain experience desirable
• Effective interpersonal and communication skills for driving effective implementation and collaborations is critical
• Strong organizational, presentation and communication skills, with an ability to synthesize and simplify complex information and data.
• Innovative and strategic thinker with broad vision
• Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution while maintaining a quality mind-set putting patent needs as a top priority.
• Ability to make decisions independently in a rapidly changing competitive landscape.

We focus on creating an inclusive organisation and welcome people who have different knowledge, perspectives, experience and working styles from across the global population.

Apply for this job: Apheresis Operations Investigator

Contact Information:

Address:  Novartis Pharmaceuticals UK Limited
Frimley Business Park
GU16 7SR
Tel:  +44 (0)1276 692255
Fax:  +44 (0)1276 692508
Website:  Visit Our Web Site

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