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Process Advisor
2 months ago
LMI seeks a Process Advisor to analyze, design, and implement improvements to the client's medical and pharmaceutical product development and manufacturing efforts using a vast array of engineering data and technical knowledge acquired over years of experience on similar projects. Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).
LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expertise in digital and analytic solutions, logistics, and management advisory services. We deliver integrated capabilities that incorporate emerging technologies and are tailored to customers' unique mission needs, backed by objective research and data analysis. Founded in 1961 to help the Department of Defense resolve complex logistics management challenges, LMI continues to enable growth and transformation, enhance operational readiness and resiliency, and ensure mission success for federal civilian and defense agencies.
We offer a generous compensation package with excellent benefits that start the first day of employment. Business casual dress, flex time, and tuition reimbursement are a few of our many work-life benefits available to our employees.
Responsibilities
- Provide onsite presence at the manufacturing office/facility, which may involve extended travel, and shall monitor and report the contractor's progress, as well as any risks, issues, or problems identified.
- Perform day-to-day oversight of activities at the manufacturing site.
- Ensure best practices and execution of current Good Manufacturing Practices (GMP) for development, manufacture, and release.
- Identify upstream and downstream process changes to enhance compliance and improve the manufacturing process. In addition, develop process flow diagrams depicting the manufacturing process.
- The contractor shall work to maintain an IMS and ensure all tasks are completed within schedule expectations.
- Assist the risk manager in risk identification, analysis, and mitigation.
- Communicate regarding technical and compliance risks and data.
- Collaborate to develop resolutions to risks or issues.
- Assist with technology transfer efforts, to include working with the PM(s) and Manufacturing Lead(s) to develop a process for transfer of data, information, materials, and knowledge.
- Review and provide comments to product transition plans, bridging studies, Technology Transition Agreements (TTAs) and Technical Data Packages (TDPs).
- Assist with multiple complex technology transfer sub-projects related to manufacturing and testing to ensure that each sub-project meets cost and schedule expectations.
- Verify that process parameters are still within the determined design space after technology transfer is complete.
- Review and critique documentation and verification associated with the technology transfer processes.
- Participate in routine and ad-hoc meetings and teleconferences to review and timely completion of action items and execution of technology transfers.
- Collaborate on and review technical documents to advance development/acquisition.
- Assist in writing and reviewing US CMC regulatory documents.
- Review documentation and support resolution of deviations through corrective and preventive actions.
- Review development and manufacturing data to ensure that processes are operating in a state of control.
- Identify process changes to enhance compliance and improve manufacturing process, as needed.
- Ensure appropriate subject matter experts are involved in the day to-day management of manufacturing efforts.
- Participate in various Government and non-Government IPTs.
- Maintain communication with supervisors, peers, or subordinates via telephone, e-mail, or in person.
- Work independently and as part of a team.
- Provide scientific and technical support for the development and transfer of medical countermeasures into the ADM facility.
- Review and provide recommendations on processes and process flows for medical countermeasures transitioning into the ADM facility.
- Provide expertise in single use systems.
- Analyze requirements and provide recommendations for optimal single use systems equipment and processes. In addition, review and provide comments for drawings and plans as they relate to modular single use systems and processes.
- Standard Requirement: PhD in Engineering, Science, Systems Management, Business Management, or a related discipline, as well as eight (8) years of general experience and five (5) years of relevant experience OR Master's degree in Engineering, Science, Systems Management, Business Management, or a related discipline, as well as ten (10) years of general experience and seven (7) years of relevant experience
- Technical knowledge of pharmaceutical manufacturing and an understanding of current GMP.
- Experience in biologics and the application of ICH Q8, Q9 QRM, and Q10.
- Experience with the development, technology transfer, process definition, process qualification, and continued process verification of drug product manufacturing.
- Strong analytical and problem solving skills, as well as good organization skills to balance and prioritize work.
- Strong interpersonal and communication skills, both oral and written.
- Active Secret clearance preferred; only candidates eligible for a Secret level clearance will be considered (US Citizenship required).
