Sr. Spclst, Biologics Operations Cell Banking Support

Job Description

Our Manufacturing Operations teams are the people that make our products. We work with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in our global manufacturing network (external & internal network) to ensure the highest quality of raw materials, intermediates, and finished products.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

The GBO Biologics External Manufacturing End to End Cell Banking Team (formerly called BioExM Cell Banking Focus Factory) is looking for a Senior Specialist, Biologics External Manufacturing Operations to support the Cell Bank Global End to End Management Team. The Cell Bank Team is responsible for the manufacture, testing, shipping, and storage of cell banks needed to supply drug substance production sites within the GBO network (Internal GBO and External (CMO) GBO sites).

The Cell Banking End to End Team Support provides support in the areas of:

• Understanding of operational aspects of biological cell bank manufacturing
• Project management and oversight capabilities
• Knowledge of SAP and Quality systems
• Lean Six Sigma methodology
• Strong communication and collaboration skills
• Dispute resolution (w/ appropriate escalation)
• Production Planning
• Materials Management
• Quality issues (Deviation Management, Product Release, Change Control)
• Technology issues (Technology transfers, Investigations, Process Improvements, etc.)
• Operational Excellence and Continuous Improvement activities
• Metrics driven operations
• Collaboration with internal and external partners as Cell Banking straddles both

The responsibilities of the Cell Bank End to End Team support include, but are not limited to:

• Leading operations owned change controls and supporting cell bank change controls
• Supporting partner, site and team interactions
• Managing transactions within SAP
• Managing storage, shipping & logistics activities for cell banks
• Track operations performance metrics
• Project Management activities
• Material management activities
• Supporting Cell Bank Supply Chain Working Group & Cell Bank (Technical) Working Group
• Support continuous improvement initiatives within the End-to-End Team and with our partners at our internal Cell Bank Manufacturing sites and our External Cell Bank CMO Partners.
• Collaborate with other Biologics External Manufacturing Operations Support personnel to leverage best practices & lessons learned across Biologics External Manufacturing Ops.

Minimum Education Requirement and Experience:

• Bachelor’s degree in Engineering, Science or Business or related fields with five (5) years’ experience in Pharma Operations

Required Experience and Skills:

• Must possess excellent interpersonal, communication, collaboration, negotiation, and project management skills.
• Demonstrated problem solving, and sensitivity to diverse cultures.
• Must possess the ability to work independently with minimal coaching.
• Some cell banking (manufacturing or testing or control) experience is preferred but not essential.

The Cell Banking End to End Team Support with work with the Cell Banking Leads (team & org) to ensure the end-to-end functioning of the Cell Bank area and will also be a back-up to the Cell Bank Lead as required.

The Cell Bank End to End Team Support stays abreast with industry and policy changes and identifies implications and opportunities for his/her area of Biologics External Manufacturing and/or Internal Cell Banking Manufacturing Organization in support of Global Biologics.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only: