Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.
The IT Manager, Research Computer Bioanalytical Systems, is responsible for the implementation and support of technology and informatics systems and programs to support the development, implementation, operation, and continuous improvement of Laboratory Operations, Clinical, Biostatistics and Data Management, Bioprocess R&D and Regulatory/Risk Management applications and technologies. The IT Manager, Research Computer Bioanalytical Systems reports to the IT Director, R&D Systems. These systems include SAS Office Analytics, Laboratory Information Management (LIMS), AWS high performance compute/storage, Electronic Lab Notebook (ELN), Linux, Windows Server, ONTAP Storage, Clinical data/imaging analysis tools, and digital tools to improve overall operations and automation. The position requires a broad understanding of regulatory frameworks and obligations. This is a highly integrated role touching many functions across the business and requires the ability to translate business problems into technology solutions, project plan, and project manage, to drive alignment and performance across the business. The position requires enthusiasm, passion, attention to detail and a desire to create new medicines for patients.
SAS Analytics Administration in an AWS environment.
Liaise with data scientists, biostatisticians and other stakeholders to understand business needs, create technology plans and inform priorities.
Partner with R&D IT managed service providers and HPC partners to ensure unified, collaborative services are provided to ProKidney business stakeholders.
Manage AWS Accounts, security IAM (Identity and Access Management) and configure account-level settings such as billing, access controls, and security.
AWS Resource Provisioning and Management through the deployment and management of AWS resources such as EC2 instances, S3 buckets, RDS databases and load balancers.
Configure monitoring tools and services to track the performance and health of AWS resources, as well as setup logging to collect and analyze system and application logs.
Monitor and optimize AWS resource usage to control costs and ensure efficient resource utilization.
Setup and manage Virtual Private Cloud (VPC), subnets, route tables, security groups, and VPN connections.
Utilize AWS automation tools such as AWS CloudFormation, AWS CLI, and AWS SDKs, to automate resource deployment and management tasks.
Resolve issues related to AWS resources, identifying root causes of problems, and providing technical support to users or other teams within the organization.
Requirements
Description
Education/Training
Bachelor’s degree in computer science or related discipline, or equivalent experience.
Experience
3+ years of implementing and supporting Clinical Trials and R&D applications in biotechnology or life sciences companies.
Strong Working Experience in developing and driving Computer System Validation program initiatives including GxP systems and ensuring CFR part 11 compliance.
Experience leveraging R&D Informatics applications to drive business workflows and processes in quality-manufacturing production environments.
Experience in establishing Posit, R and/or Python technology environments and establishing the use of AWS high-performance computing environments.
Experience implementing AWS High Performance Computing solutions.
Previous experience in the biotechnology / pharmaceutical industries and GMP Quality Systems. Experience with key business solutions such as QMS, ERP, LIMS, ELN, SAS
CRO experience highly preferred.
Skills/Abilities
Strong project and portfolio management skills. Ability to oversee multiple projects, activities and tasks simultaneously.
Strong technology background SaaS/PaaS cloud service application management to include AWS and Azure.
SAS Office Analytics administration
Linux and Windows server administration
Database, Data Warehouse, Databricks design and administration
Data visualization tools such as Spotfire, Tableau, Prism, Power BI
ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment.
Top Skills
What We Do
ProKidney (Nasdaq: PROK), a pioneer in the treatment of CKD through innovations in cellular therapy, was founded in 2015 after a decade of research. ProKidney’s lead product candidate, REACT™ (Renal Autologous Cell Therapy), is a first-of-its-kind, patented disease-modifying autologous cellular therapy with the potential to not only slow and stabilize the progression of CKD, but in some cases potentially drive meaningful improvement in kidney function. Late-stage CKD, Stage 3b - 4, is a key target for REACT™ therapy. REACT™ has received Regenerative Medicine Advanced Therapy (RMAT) designation, as well as FDA and EMA guidance, supporting its ongoing Phase 3 clinical program, which launched in January 2022. For more information, visit www.prokidney.com.
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