Process Control Manager

Job Title: Process Control Manager

Job Location: Sanford, NC

Job Type: Contract

Role Responsibilities

Individual Accountabilities:

Participate in clinical product tech transfer, production and capital projects in a technical leadership capacity. Perform technical transfer and process engineering activities with minimal supervision to implement processes in the manufacturing areas. This may include leading and/or assisting in the technical transfer of processes from development laboratories and small-scale pilot areas into the clinical production areas, as well as technology transfer from clinical to commercial facilities.

As Microbial And Conjugate Antigens Progress Through The Research Pipeline From Development Through Phase III Clinical Production, The Incumbent Will Work With Internal And External Development Colleagues To Map Processes To The Manufacturing Facilities. This Includes The Following

• Provide lead process engineering knowledge and execution in process design from initial design specifications through implementation including testing during engineering projects. Collaborating with the Site, Engineering & Maintenance (SEM) department and outside engineering firm personnel will be critical to successful outcomes. Develop new process procedures (i.e., CIP/SIP paths, WFI flush, blowdown, waste removal, stat paths) and review closely with SEM automation team and Technical Operations team. Perform calculations to ensure correct equipment sizes are in place for new processes. Lead procurement of process equipment. Develop process flow diagrams for illustrating the critical process and material flow.
• Review, recommend and execute process improvements and optimizations to existing processes with engineering principles (i.e., SIP/CIP optimization, cycle time reduction, equipment efficiency, PAT). Analyze root causes of process problems including but not limited to equipment failure, instrument malfunction, automation changes, and recommend technical solutions. Develops guides and executes implementation of solutions to complex process engineering problems.
• Serves as the technical lead for technology transfer projects by serving as the point of contact with internal and external sending site customers. Ensures relevant technical information is relayed to group members and manufacturing colleagues and solicits this personnel for feedback and improvement. Works with manufacturing to ensure readiness prior to the start of a production campaign.
• Understand and provide input to the development of detailed process flow diagrams and step-by-step process fits of unit operations. Create, edit and maintain SOPs, Master Batch Records and Compounding Records needed for new projects within the approved QA document management system. Lead the revision process of documents as they evolve during the technical transfer and development process. Track approval of new and revised documents through the QA document approval process.
• Collaborate with development personnel during engineering practice runs to introduce a variety of product candidate processes into clinical production areas through effective process scale-up and troubleshooting activities. This includes adjusting process parameters as necessary during engineering runs and pursuit of any necessary equipment/automation refinements to ensure optimized process performance prior to demonstration runs. Ensure that the process adjustments are incorporated into the appropriate final version of SOPs, Master Batch Records and Compounding Records. Provide suggestions for innovative approaches to scale-up issues related to new projects. Incumbents must be able to recognize unique differences among different antigen processes and contribute to the scientific team that works through the issues encountered. The incumbent is aware of new process parameters co-developed with colleagues and is able to introduce them into the process with area champion or supervisor input.
• Maintain careful and accurate records of process and analytical data and findings on development projects. Utilize data and findings to contribute to meetings and make presentations on specific process issues. Provide observations/comments during schedule planning and process development meetings. During demonstration and clinical production campaigns, the incumbent will function as the process subject matter expert and will execute batch production and provide leadership to the manufacturing teams. The incumbent will also perform real-time troubleshooting of equipment and process operations to ensure successful batch completion.
  
  

Additionally

• Coordinates the development and execution of studies to identify, resolve and/or correct manufacturing problems or process improvements, producing reports to substantiate findings, and establish validation acceptance criteria.
• Participates in all internal and external audits related to validation activities.
• Takes a leadership role in cross-functional teams to resolve problems to optimize output, minimize contamination, and minimize cost.
• Provide effective leadership and direction to Technical Operations personnel; build and develop talent and work with the regional/global teams to ensure key talent is developed across locations/businesses
• Support and enhance the technical capability of the manufacturing environment including process control and improvement. Implement process control and reporting tools to ensure process trends are reviewed in a timely manner
• Interact with Manufacturing Operations, Engineering and Product Development groups to proactively assess people/facilities capabilities and capacity
• Ensure consistency of application of validation concepts across the site and the network.
• Accountable for ongoing compliance of all process and cleaning validation activities with cGMP requirements.
• Provide day-to-day support for technical issues in Mfg.
  
  

Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical Manufacturing department. Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities. Review company and site-specific SOPs, policies, and procedures and develop processes that meet the quality requirements set forth in these documents.

About Us

InterSources Inc, a Certified Diverse Supplier, was founded in 2007, offers innovative solutions to help clients with Digital Transformations across various domains and industries. Our history spans over 13 years and today we are an Award-Winning Global Software Consultancy solving complex problems with technology. We recognize that our employees and our clients are our strengths as the diverse talents and opportunities they bring to the table enables us to grow as a global platform and they are causally linked with our success. We provide strategic and technical advice, and we have expertise in areas covering Artificial Intelligence, Cloud Migration, Custom Software Development, Data Analytics Infrastructure & Cloud Solutions, Cyber Security Services etc.

We make reasonable accommodations for clients and employees and we do not discriminate based on any protected attribute including race, religion, colour, national origin, gender sexual orientation, gender identity, age, marital status.

We also are a Google Cloud partner company. We align strategy with execution and provide secure service solutions by developing and using the latest technologies that thrive our resources to deliver industry-leading capabilities to our clients and customers, making it convenient for our clients to do business with InterSources Inc. Our teams also drive growth by refining technology-driven client experiences that put the users first, providing an unparalleled experience. This results in strengthening the core technologies of clients, enabling them to scale with flexibility, create seamless digital experiences and build lifelong relationships.