Associate Director, Process Analytics
3 weeks ago
The Associate Director, Process Analytics is the system owner for this function, focusing on the drug substance manufacturing at FDBN. This role sets up and maintains
informatics systems for process analytics purposes, leads projects to create new process analytics systems, and expands the capabilities and functionalities.
This role also supports Process Science for the drug substance group, and ensures the systems support the business processes in place for the site.
Additionally, this role creates multivariate models and provides training in the use of process analytics systems that are currently in place
Major Accountabilities
Builds the Process Analytics team and develops the team to deploy digital solutions for real-time process monitoring and multivariate statistical process control
Supervises the Analytics team and sets the direction for individual and team goals
Leads the architecture, design, and deployment of site's process data platforms to allow machine learning models, data science applications, and other custom applications and dashboards
Leads the Process Analytics team in developing and maintaining internal data-focused webapps to support different stakeholders
Seeks to continuously optimize the data management of manufacturing processes while focusing on digital solutions
Partners with users (internal and clients) to define functional specifications and process requirements from a process data perspective,
specifically process data transmittance (sensor, control, and operation data)
Partners with users (internal and clients) for data used to support continuous manufacturing and validation, continuous improvement and regulatory commitments
Leads innovations and systems improvement initiatives in the Process Analytics space (e.g., new in-line and on-line Process Analytical Technologies
(PAT) solutions for biopharmaceutical processes with a strong focus on drug substance production process monitoring and control)
Trains relevant stakeholders on PAT tools and respective analytical approaches (e.g., multivariate models and other statistical process methods)
Establishes systems and procedures to enable proactive process monitoring, analysis, and reporting of manufacturing process data
Provides team support for investigations, root cause analysis, and optimization with data support and analysis
Functions as senior technical data leader and contact for process data, statistics, modeling, and PAT activities (e.g., automation interface between PAT analyzers and sensors and data systems)
Leads team in curating critical knowledge and developing best practices in Process Analytics space
Serves as a key stakeholder in business development and defining the future large-scale operations model, including site's digital roadmap of GxP process data
Designs and leads the development of applications and methods with model for process characterization and scale-up/out (e.g., transition analysis to monitor column integrity, e-chromatogram review)
Coaches and mentors direct reports and team members to foster professional development and growth
Enforces and ensures team adheres to company policies and procedures
Participates in the recruitment process to attract talent
Collaborates with other departments (e.g., HR, Talent Acquisition) and provides input to develop retention strategies
Addresses employee concerns and partners with HR for resolution, as needed
Evaluates team performance and address gaps appropriately
Other duties, as assigned
Knowledge, Skills and Abilities
Strong knowledge of US and international regulatory standards and ICH guidelines especially with regards to data integrity
Knowledge of PAT methodologies and implementation
Knowledge of SIMCA-Online, TIBCO Statistical, Visual Basic and Git version control
Strong attention to detail, highly organized, and solution-oriented mindset
Ability to multitask in a fast-paced, highly interactive environment
Ability to adapt communication style to differing audiences and advise others on difficult matters
Effective communication, both written and oral
Ability to effectively present information to others
Ability to provide feedback to others, including leaders
Advanced problem-solving skills
Demonstrated ability to hire and develop top technical talent to build and lead a high performing team, projects, programs while directing allocation of resources
Must be willing to travel domestic and international, 10-20%
Minimum Requirements
Bachelors degree in Engineering, Scientific or Mathematics field with 15 years of relevant experience (e.g., Statistical Control of Manufacturing Processes or Development of Data Collection/Management Systems); or
Masters degree with 12 years of relevant experience
Previous management or supervisory experience
Working-knowledge of structured query language (SQL) and experience with data science and the Python data science ecosystem (e.g., NumPy, SciPy, pandas, Scikit-learn, Jupyter Notebook)
Prior experience with data mining, management and visualization, statistical process control, and manufacturing processes
Preferred Requirements
Experience working in a Good Manufacturing Practices (GMP) environment
Experience using IT systems to support data acquisition, management, and evaluation
Prior experience collaborating and interacting with a global team
Experience with multivariate data analysis
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