Senior Engineer, Laboratory Applications & Informatics

Resilience is ushering in an era of “Biomanufacturing-as-a-Service” that we expect will displace in-house manufacturing as well as traditional contract manufacturing and development organizations (CDMOs). We see this as a paradigm shift in biomanufacturing akin to the IT industry’s adoption of Infrastructure-as-a-Service (IaaS) and Platform-as-a-Service (PaaS) that rendered obsolete corporate-owned/operated data centers or corporate servers co-located in hosting facilities.

This role is the technical leader for the harmonized design, deployment, and management of Research and Development (R&D) Applications & Informatics specializing in developing scientific capabilities for Resilience’s R&D Engine. This includes, but not limited to, gathering/defining user requirements, implementation, testing, training, maintenance, and support. The preferred candidate will thrive in a dynamic, multidisciplinary environment and use their experience and creativity to support the mission of creating industry-defining biomanufacturing technologies that will improve access to the next generation of complex medicines.

This role requires strong technical and analytical skills, familiarity with scientific data problems, as well as extensive problem-solving skills. They will bring advanced understanding of laboratory processes and instrumentation and will work with vendor-based consultants and services to ensure continued operation of commercial off the shelf (COTS) systems, development of technical solutions, and interfaces and integrations to other systems (e.g., ELN, Data Acquisition, Process Data System, Inventory).

Responsibilities

• Manage Digital R&D system implementation projects, which may include requirements elicitation, technology evaluation, software configuration, customization, testing, and scientist knowledge transfer.
• Identify, prototype, and deploy integrations with other R&D systems (e.g., ELN and data acquisition systems) and understand the technical architecture. Support data exchange activities with interfaced systems.
• Provides training and support to scientific staff in the use of automation systems.
• Define, implement, and promote mechanisms to ensure standardized implementation, operation, and maintenance of Digital R&D Systems across all Resilience R&D laboratories.
• Drive in the development, implementation and maintenance of best practices, policies, standards, and procedures for Digital R&D systems across the Resilience network.
• Document as-is and to-be states of R&D processes; create and maintain detailed R&D business maps, business requirements documents, and technical requirements documents.
• Responsible for troubleshooting technical and validation issues that arise in the support of the support of Digital R&D systems (e.g., ELN, SDMS).

Qualifications

• Advanced experience with the implementation of R&D computerized systems (e.g., Benchling, Dotmatics, Sapio) in the pharmaceutical or biotechnology industry is required.
• Must possess expert knowledge of laboratory technology systems development life cycle, computer systems validation, application development or systems integration.
• Technology agnostic. Must possess the ability to adapt, learn and apply the correct technology at the right time and not be biased towards an underlying platform or technology. (e.g., Java only).
• Proficient knowledge of programming languages in support of Data Engineering or Bioinformatics (e.g. Python, SQL, C#, Java).
• Excellent oral and written communication skills with strong technical writing experience required.
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders.

Preferred Experience

• Knowledge of Benchling with expertise and experience in developing schemas, integrations with lab automation and use of the data warehouse.
• Strong technical aptitude and the ability to learn new processes and systems rapidly.
• Knowledge of project/demand planning tools (e.g., Jira, Confluence, Smartsheet, etc.)
• Knowledge of biopharmaceutical production desirable.
• Knowledge of industry standards related to validated computerized systems and GAMP5.
• Familiarity with the Cloud preferably AWS and key approaches to security and change management/deployment.