Continued Process Verification Expert
Duchnice
Boost your career with us
Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!
Your role
This role is a strategic role and helps to align best practices of using data analytics and statistical analysis for technical and cross-functional/cross company business issues. This role is expected to provide in depth technical knowledge and leadership in data analytics and its application, especially In driving lean behavior, problem solving, preventative action, and continuous improvement. This position will serve to drive implementation of Continued Process Verification. The person will develop, implement, and drive improvement of data analytics and business processes as applied to continued process verification, including both process and method capability analysis.
Your responsibilities
- Represent Manufacturing Science and Technology (MS&T) as a Continued Process Verification (CPV) Subject Matter Expert (SME) to coordinate multi-functional activities relating to CPV data collection, document generation and CPV investigations.
- Participate in cross functional business and scientific initiatives as the MS&T representative, and effectively collaborate and influence cross-functional partners to support MS&T objectives.
- Support the CPV activities ensuring strategy design is in alignment with business needs, regional & global regulatory compliance.
- Develop and standardize complex statistical analysis techniques for product development, technology transfer, manufacturing process validation and routine commercial product analyses.
- Makes use of statistical software packages such as R, MINITAB, Discoverant or other data manipulation software packages in the evaluation of Product Quality Review, in-process product, and special investigation data on a regular basis for all products.
- Provides subject matter expertise in designing and statistically evaluating analytical and process validation studies, trouble-shooting, including but not limited to data analysis support, and data preparation for international regulatory submissions.
- Create and review technical documentation including protocols, technical investigations and reports related to CPV.
- Support regulatory inspection readiness and product compliance with regional regulatory requirements.
- Partnering with cross functional Departments, support investigations and data analysis as SME to address OOS, OOT, complex deviations/non-conformances and implement change controls to ensure timely/prompt release of batches to meet regional demand forecast and ensure CAPAs are in place.
- Analyzes data from investigation evaluations, summarizes conclusions and makes recommendations for further work where necessary.
- Support improvement of data collection and management to enable quick and reliable data analysis.
- Drive activities related to design, development, and implementation of processes and technology related to reporting of product performance metrics (Product Technical Dashboards, Method Capability Reports, KPIs, Signal Monitoring Dashboards, Success rate and yield, etc.) in a way that ensures continuous improvement of products, methods, and processes.
If you have
- A Master of Science Degree in Statistics, Engineering, Mathematics, or one of the life sciences is required.
- A minimum of 5 years of pharmaceutical industry experience is required with Pharmaceutical Development, Statistical/Data analytic support of commercial manufacturing and/or research experience preferred.
- Experience working with multiple manufacturing sites/laboratories, including contract manufacturing / laboratories is highly desired.
- Expert understanding of CPV and its application.
- Expert understanding of how continued process verification can be implemented to Biologics.
- Experience with statistical data analysis tools.
- A working knowledge in applying a wide range of statistical and data analytics analyses.
- Strong organizational skills.
- Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred.
- Excellent troubleshooting skills and ability to solve complex technical issues.
- Ability to understand and simplify complex processes.
- Understanding of guidelines required by FDA, EMA, and other regulatory bodies.
- Strong interpersonal and communication skills, verbal and written.
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
- High degree of technical competence and effective communication skills, both oral and written.
- Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
- Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo.
- Very good command of the English and Polish language.