Global Technical Development (PTD) is an organization of over two thousand people globally that are 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. The mandate of the group is, to reliably deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every day, continuously improving what it does.
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. We collaborate closely with key partners in the departments Research and Early Development (pRED / gRED), Manufacturing (PT) and Quality (PTQ).
Reporting to the PTD Principal Systems Manager in SSF, the position will be accountable for management and support of PTD lab information management systems including LIMS, ELN, and HPLC Data Systems. You will serve as a subject matter expert for configuration, implementation and ongoing support of solutions used in a laboratory environment for process development in both GMP and non-GMP environments.
In this role you must be able to understand vendor’s software strategy, information of available competing solutions and the ability to translate these to the changing business environment in PTD such that we can continually maximize software investments. This role requires to be collaborative across PTD labs globally. You must be able to anticipate systems problems, develop multiple solutions, document the rationale, and secure business approval for solution implementation. In the role it is crucial to be customer-service oriented, sensitive to the needs of the client groups and receptive to their feedback.
You will be responsible for following tasks:
- Manage and support PTD lab information management solutions including LabwareLIMS, Electronic Lab Notebook software (IDBS E-Workbook ELN), and Chromeleon Chromatography Data System (CDS)
- Develop and drive new solutions for the lab systems users across PTD; partner with PTDxfunctions and external vendors to assess needs
- Provide support for lab data analysis solutions (e.g., Matlab, Excel, Jump and SAS) andinstrument specific software (including robotics and automation equipment)
- Participate in strategic planning and contribute towards implementation of data management solutions for multiple functions to ensure data accessibility, interoperability, quality, and integrity
- Work within a team environment to provide end user support in a complex environment with occasional 24 x 7 support
- Produce end user documentation and training materials for both, a GMP and non-GMPenvironments
- Manage and lead consultants and technical experts from software vendor companies
- Communicate effectively with key stake holders and senior management
- 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 science, computer science, engineering, business or a related discipline; advanced degree in related field (Bioinformatics, Biomedical, Biotechnology)is strongly preferred
- 5+ years of relevant experience or combination of advanced degree and experience in providing informatics solutions to business problems. Developing and managing GxP IT systems with a focus on IT solution delivery, quality IT support and client services in biotech, pharmaceuticals, medical device, diagnostic, or other relevant industry
- Demonstrated experience managing lab software for both chemistry and microbiologicalmethods , Analytical Development/Formulation including managing software and hardware requirements, software configuration, end user training, documentation management, data management, and lab instrument software management
- Working knowledge of software platforms used in GMP Quality Control Laboratories,pharmaceutical manufacturing, microbiological techniques, environmental monitoring,applicable FDA guidance, and 21 CFR parts 210, 211 and Part 11
- Experience with implementing validated GxP systems is desired
- Hands-on experience with ELN, Template development, life science platforms like Biovia, Chemaxon or Dotmatics is a plus
- Use knowledge of full stack software development skills (Java, Python, REST, Oracle, MongoDB) in implementing IT solutions and a good understanding of Machine Learning and Deep Learning concepts and their areas of application
- Familiarity with relational and non-relational databases, scripting languages, and data visualization tools Tableu and spotfire. Working knowledge of scientific research applications development cycles, data management techniques and infrastructure requirements
- High level of motivation and ability to commit to results and implement pragmatic solutions with flexibility to change and “out of the box thinking” ability
- 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
- Ability to travel 25% of the time