Vignetic
Microsoft Dynamics 365 IT Business Administrator Pittsburgh, PA
Title: Microsoft Dynamics 365 IT Business Administrator
Job Type: Permanent
Primary Location: Pittsburgh, PA
The Challenge:
Our client is seeking a highly motivated Business Application Business Partner within it’s IT Team to support operations and development. The Business Application Manager covers a critical position supporting 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.
Role and Responsibilities:
- Partner with senior business stakeholders and key users to lead and support the ongoing Microsoft Dynamix 365 across CMC
- As a hands-on technology administrator manage multiple CMC and Quality systems
- Work as technology integration lead for process control systems, historian, manufacturing execution systems
- Manage security and implementations of relevant applications
- Align CMC technology platforms and activities across commercial and clinical supply chains, ensuring business solutions are implemented through out-of-box and customized solutions
- Manage and mature 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
- Cooperate closely 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 CMC and Clinical Operations 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
- Advise, inform, and support the application system owners and super-users 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
- Contribute to clinical supply systems implementation, provide appropriate operational support levels, and further develop adopted technology to sustain business growth
Essential skills and requirements:
- A scientific and/or technical degree level qualification within Computer Science, Computer Engineering, Chemical Engineering or similar
- ERP experience, esp. Microsoft Dynamics 365 is highly preferred.
- 5+ years’ experience with technologies in CMC e.g., PCS, historian, integration, ELN
- 5+ years’ hands-on experience in clinical systems preferred (EDC, CTMS, PV)
- Veeva vault experience preferred.
- 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
- Strong experience in liaising and managing third party vendor managed services where required to support the application portfolio and integration layer
- Experience in project management, data management, and training and support is required
- Comfort level to interact with users from different departments and at all levels
- Self-managed and motivated individual with strong analytical and quantitative analysis skills
- Knowledge of service center processes and workflows
- Strong interpersonal skills and strong team player
- Ability to meet deadlines under pressure
- Risk management and contingency planning
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