Position Summary:
Provide support to develop and implement data repository and analytics tools in support of pharmaceutical regulated GMP (Good Manufacturing Practices) data and with the focus on manufacturing and quality domains.
Essential Duties & Responsibilities:
- Analyze business needs and requirements for data and analytics to support regulatory filings.
- Identify, classify, and map data sources.
- Build data lineage diagram from data source to analytics ready datasets
- Determine data curation requirements to help organize, clean, manage, and maintain data so it can be used reliably for analytical use cases.
- Provide support for technical activities such as building data integration, design data architecture, and data transformation and processing.
- Develop data governance standards to comply with company and industry best practices.
- Lead development of key project documents such as user requirements, design specifications, and configuration specifications.
- Lead development of test scenarios and scripts in partnership with business, technical, and validation team members.
- Lead test execution according to test protocols.
- Provide support for development of standard operating procedures and other documentation required to go-Live.
- Monitor execution of testing and relay results to technical team to address issues.
- Provide support for training business teams for Go-Live
- Development of training materials as needed
- Provide regular updates to project team
Qualifications:
- Education/Training: Bachelor’s Degree.
- Experience:
- Minimum of 5-10 years of experience in IT experience working in the role of business and technical analyst with the focus on data, business intelligence, and analytics projects
- Experience working in Biotech/Pharma (Regulated Industry)
- Experience with developing requirements, design, and testing documents.
- Hands-on experience with data analysis and reporting in support of Pharmaceutical GMP environment.
- Understanding of GMP data sources across pharmaceutical manufacturing process and quality control testing environment sources such as Laboratory Management Information Systems, Quality Systems, Manufacturing Execution Systems, Data Historian, and other tools.
- Experience with design and development and usage of data repository and analytics platforms
- Demonstrated experience managing lifecycle documentation and validation in FDA-regulated environments.
- Versed in FDA/Industry regulations and policies (Part 11, Computer System Validation)
- Experience with system administration responsibilities
- Experience with helping lead data analysis and engineering projects
- Ability to work under tight timelines
- Ability to communicate and work across teams in collaborative manner
- Ability to work independently with minimal supervision
- Knowledge:
- GxP, Pharmaceutical Manufacturing and Quality Data (GMP data), Data analysis and reporting
- Understanding of data modeling tools
- Experience working with analytics (Python, R, Excel, Tableau, Spotfire, other reporting and analytics for manufacturing process industries)
- Experience with database (SQL) and ETL development
- Experience with cloud environments (AWS, Azure)
- Experience with usage of process analytic software is a plus (Aveva, Seeq).
- Skills:
- System Support/System Administration, Communications, Project Management, Training, Computer System Validation, Business Requirements Documentation.
- Certifications/Licenses: None
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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.
