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Business Application Manager, CMC

The Role

The Business Application Manager will be part of the Business Applications Management Team taking on an embedded role within the CMC team in the Global IT, Digital team unit, based in Copenhagen, Denmark. In this role, the candidate will manage multiple business applications in Manufacturing environment and ensure compliance with applicable procedures and regulatory requirements. 

The Business Application Manager covers a critical position supporting the IT Platforms and Software Applications primarily focused on the Global Chemistry, Manufacturing, and Control (CMC) Operations domain. In collaboration with internal and external partners this position will provide leadership to ensure continued steady state operations of business applications in scope. The candidate will ensure the new features meet business needs and are implemented with speed, focus, and impeccable quality standards.

This position reports into Global IT and the Senior Director Global IT ERP.
 

Responsibilities 

  • Manage and mature CMC technology platforms to align activities across Drug Substance, Drug Product and Finished Goods in clinical and commercial supply chains ensuring business solutions are implemented through out-of-box and customized solutions

  • Partner with senior business stakeholders and key users to support and develop analysis systems for CMC Stability Data Management (e.g., ScienTek iStability) and Manufacturing Data Management (e.g., Skyland PIMS) Furthermore we are currently deploying a TraceLink based Serialization solution

  • Contribute to Clinical Drug Supply/IRT (Interactive Response Technology) systems implementation, provide appropriate operational support levels, and further develop adopted technology to sustain business growth

  • Cooperate closely with the CMC Team to anticipate high-level potential risks and identify contingency/mitigation plans and enlist key people to resolve obstacles to expedite drug development process through all phases

  • Partner with cross functional IT & CMC, Clinical Operations and CRO teams to integrate technology solutions and manage product lifecycle projects, change requests, enhancements, and releases

  • Establish strong strategic relationships and act as point of contact across business stakeholders to develop a deep understanding of the business strategy and operations

  • Liaise with project team members to maintain accurate and current project plans and metrics according to regulations and corporate SOPs 

  • Advise, inform, and support the application system owners and super-users within Genmab and act as a first line of support for business application related issues or requests

  • Manage day-to-day user cases, including (but not limited to) new user requests, resolution of operational systems issues, and troubleshooting of various business applications in scope

  • Define yearly OPEX budget and provide periodic financial reports pertaining applications within scope of responsibility

 

Requirements 

  • 5-7 years’ experience in the CMC biotechnology development area and manufacturer of pharmaceutical products

  • Drug development knowledge with understanding of interdependencies between functions relevant to the position which may include R&D, Manufacturing, Nonclinical and Clinical Development, Regulatory, Supply Chain, and Commercial 

  • Knowledge of FDA, EMA and ICH regulations and industry standards

  • Understanding of GMPs, GDP and GLPs and Biopharmaceutical Product Development 

  • 5-7 years’ experience coordinating IT application-based activities within a life science focused organization

  • A scientific and/-or technical degree level qualification within Computer Science, Computer Engineering, Chemical Engineering or similar

  • Strong experience in liaising and managing third party vendor managed services where required to support the application portfolio and integration layer

  • Capable of operating well in an international and cross-functional, fast-paced team environment, build consensus and drive resolution of problems while maintaining positive working relationships across functions with both business and technical priorities

Degrees of interest: CMC biotechnology development area and manufacturer of pharmaceutical products

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