Global Technical Development (PTD) is an organization integral for the mission of Roche to develop meaningful medicines for patients. Therefore, PTD actively collaborates and develops innovative technical solutions to bridge early-stage, late-stage and commercial product needs.
PTDO Informatics Team is responsible for a broad range of IT services and support across small and large molecule technical development, device development, analytical sciences, business operations and supply chain in PTD. We provide lab information management systems, data management solutions and web applications to support PTD functions.
Reporting to the Principal Systems Manager of Informatics, the position will be accountable for client services, IT vendor management, business analysis, collecting new demand, coordinating and executing software upgrades, lab IT systems operational support for both GMP and non GMP IT platforms, defining business requirements for new/enhanced functionality, maintenance of the system configuration and associated documentation, and implementation support. The incumbent will work closely with Roche Global Informatics services and Pharma Informatics to deliver quality services. He/she must be customer-service oriented, sensitive to the IT needs of the client groups and focused on vendor management.
- Under the supervision and direction of Principal Systems Manager and senior team members of PTDOI execute on IT/Informatics support requests which come from lab space. Be the point person for scientific users to ensure IT systems are meeting their business needs.
- Work closely with scientific staff to understand their information management needs, assist in collecting new demand/new requests. Analysis of new requests and do scope analysis, preparation of proposals and SOW’s, vendor and COTS solution evaluation and work with IT manager to define implementation strategy and plan to roll out new demand.
- Work on service requests and collaborate with informatics/ infrastructure personnel to deliver on IT/informatics needs.
- Maintain GMP IT systems in their validated state as IT system owner. Evaluate and assess need for change requests to make changes to validated systems. Work with quality and validation leads to draft, review and execute validation deliverables and test scripts.
- Experience in handling multiple requests/projects that require interacting with user community and technical teams.
- Create direct channels of communication to software and application developers that get the job done without constant managerial interjection
- Demonstrated experience in providing IT support and solution implementation in scientific domain.
- Develop scope documents, determine and document User/ Business requirements/Narrative Use Cases, User Stories for business processes, produce end user documentation and training materials.
- Act as a coordinator to track, plan and deliver on IT tasks. Provide regular project progress and status to IT management and business stakeholder/interested parties.
- Bachelor’s degree in life science, computer sciences, engineering, business or a related discipline.
- Five years working as a BSA providing informatics solutions to business problems, developing and managing IT systems with a focus on IT solution delivery, quality IT support and client services in biotech, pharmaceuticals, medical device, diagnostic, management consulting or other relevant industry.
- Individual with excellent customer relationship and IT vendor management skills with an IT delivery service-minded attitude.
- Demonstrated experience collaborating effectively across multiple IT functions and customer groups.
- Desired experience with digital transformation projects and cloud based solutions.
- Demonstrated experience managing lab software for scientific domains including managing software and hardware requirements, software configuration, knowledge of networks, and lab instrument installation.
- Working knowledge of software platforms and instruments used in GMP Quality Control Laboratories, pharmaceutical manufacturing, applicable FDA guidance, and 21 CFR.
- Hands-on experience with ELN (preferably IDBS and Benchling), Template development, life science platforms like Biovia, Chemaxon or Dotmatics is required.
- Hands on experience with instrument controllers like Chromeleon, empower a plus along with support of Mass Specs, LC and HPLC’s is desired with focus on data storage, archiving and data retrieval.
- The successful candidate will be a strong team player, proactive, outgoing and detail-oriented with excellent organizational & follow up, problem-solving and written/verbal communication skills.