Process Analytics Associate Director
4 weeks ago
Overview
Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO
The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.
Join us
We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.
The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.
About This Role
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
• Bachelor’s 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
• Master’s 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
-
Process Analytics Associate Director
4 weeks ago
Holly Springs, United States FUJIFILM Diosynth Biotechnologies Full timeOverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make...
-
Holly Springs, North Carolina, United States Fujifilm Full timeAbout This RoleThe Associate Director, Process Analytics and Optimization is a key leadership position responsible for driving the development and implementation of advanced analytics and process control solutions across Fujifilm's manufacturing operations.Key ResponsibilitiesDevelop and execute a strategic plan for process analytics and optimization,...
-
Senior Analytical Chemist
3 days ago
Holly Springs, United States FUJIFILM Corporation Full timeAbout the RoleThe Senior Analytical Chemist works with limited direction to execute QC analytical chemistry methods used in biological product manufacturing, including chromatography, spectroscopy, electrophoresis, wet chemistry, glycan analysis, sub-visible particle analysis, peptide mapping, and physical appearance, etc. The Senior Analytical Chemist...
-
Senior Process Engineer
2 weeks ago
Holly Springs, United States FUJIFILM Corporation Full timePosition Overview:This role is integral to the Process Equipment team, reporting directly to the Director of Process Engineering. The selected candidate will play a crucial role in supporting a significant expansion project. The initial focus will be on overseeing the engineering responsibilities for specific equipment.As operations transition to commercial...
-
Senior Process Engineer
2 weeks ago
Holly Springs, United States FUJIFILM Corporation Full timePosition OverviewThis role is under the supervision of the Director of Process Engineering, focusing on the Process Equipment team. The selected candidate will play a crucial role in supporting a significant expansion project. The initial responsibilities will include overseeing the engineering aspects of washers and autoclaves.As the facility transitions...
-
Lead Process Engineering Specialist
2 weeks ago
Holly Springs, United States FUJIFILM Corporation Full timePosition Overview:This role is integral to the Process Equipment team, reporting directly to the Director of Process Engineering. The primary focus will be on supporting a significant expansion project. The initial responsibilities will involve taking on the role of Responsible Engineer for specific equipment.As the site transitions into operational phases,...
-
Director, Process Transformation
4 weeks ago
Colorado Springs, United States USAA Full timeWhy USAA?Let’s do something that really matters.At USAA, we have an important mission: facilitating the financial security of millions of U.S. military members and their families. Not all our employees served in our nation’s military, but we all share in the mission to give back to those who did. We’re working as one to build a great experience and...
-
Associate Director, FP&A
3 weeks ago
Cambridge Springs, United States Ipsen Biopharmaceuticals, Inc. Full timeTitle: Associate Director, FP&A Company: Ipsen Biopharmaceuticals Inc. Job Description: The Associate Director (AD), FP&A is accountable for internal financial reporting and forecasting in support of assigned Ipsen Biopharmaceuticals Functions supporting the North America (NA) commercial operations. This position will...
-
Executive Director of Analytical Operations
6 days ago
Santa Fe Springs, California, United States Element Materials Technology Full timeJob SummaryElement Materials Technology is seeking an experienced Executive Director of Analytical Operations to lead our Santa Fe Springs, CA laboratory. As a key member of our leadership team, you will be responsible for driving operational excellence, fostering colleague engagement, and delivering exceptional results to our customers.Key...
-
Senior Process Engineering Specialist
2 weeks ago
Holly Springs, United States FUJIFILM Corporation Full timePosition Overview:As a pivotal member of the Process Engineering team, you will report directly to the Director of Process Engineering. This role is essential in supporting the Process Equipment team, focusing on high-stakes projects within the biopharmaceutical sector.Key Responsibilities:Act as the primary liaison with the Engineering, Procurement, and...
-
Advanced Process Engineer
2 weeks ago
Holly Springs, United States FUJIFILM Corporation Full timePosition Overview:This role is integral to the Process Engineering team, reporting directly to the Process Engineering Manager in the Downstream sector. The selected candidate will play a pivotal role in supporting a significant construction initiative. The primary focus will be on assuming the Responsible Engineer duties for Ultra Filtration (UF) and Viral...
-
Associate Director, Database Management
22 hours ago
Saratoga Springs, New York, United States InsideHigherEd Full timeJob SummaryWe are seeking a highly skilled and experienced Associate Director, Database Management to join our team at InsideHigherEd. The successful candidate will be responsible for overseeing the management of our advancement databases, ensuring data integrity and security, and providing strategic leadership to our database management team.Key...
-
Senior Operations Manager
4 days ago
Dripping Springs, Texas, United States Clinical Pathology Laboratories, Inc Full timeJob Summary:We are seeking a highly skilled and experienced Senior Operations Manager - Pre-Analytics to join our team at Clinical Pathology Laboratories, Inc. As a key member of our laboratory operations team, you will be responsible for overseeing all Pre-analytic operations during the day, supporting the Laboratory Director with organizational goals and...
-
Apprentice Manufacturing Associate
1 week ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Do more with the knowledge youre working hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will have the...
-
Apprentice Manufacturing Associate
1 week ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Do more with the knowledge youre working hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will have the...
-
Senior Engineer
1 month ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology...
-
Lead Process Engineering Specialist
2 weeks ago
Holly Springs, United States FUJIFILM Corporation Full timePosition Overview:This role is under the supervision of the Process Engineering Manager, focusing on the Downstream sector, specifically within the Process Equipment team. The primary responsibility involves supporting a significant construction initiative. The initial task will be to take on the Responsible Engineer role for Ultra Filtration (UF) and Viral...
-
Senior Engineer
1 month ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...
-
Apprentice Manufacturing Associate
7 days ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will...
-
Apprentice Manufacturing Associate
7 days ago
Holly Springs, United States Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION? Do more with the knowledge you’re working hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Through this program, you will...