Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.
Summary:
Goldbelt Apex LLC is seeking a qualified Process Advisor III to support our Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear (JPEO-CBRND) Joint Project Manager for Medical Countermeasure Systems (JPM MCS) client at our Ft. Detrick, MD location. This position requires an active Secret clearance. You must be a U.S. citizen.
ResponsibilitiesEssential Job Functions:
Provide an on-site presence at the manufacturing office/facility, which may involve extended travel. Monitor and report the contractor's progress and any identified risks, issues, or problems.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.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, including working with the PM(s) and Manufacturing Lead(s) to develop a process for transferring data, information, materials, and knowledge.Review and comment on 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 the technology transfer.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 complete action items and execute 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 the resolution of deviations through corrective and preventive actions.Review development and manufacturing data to ensure that processes are under control.Identify process changes to enhance compliance and improve the manufacturing process.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.Ensure that the CMO(s) meets best practices and execution of non-GMP manufacture of analytical reagents (e.g., recombinant Glycoproteins, monoclonal/polyclonal antibodies, etc.) used in the testing of vaccines during manufacture (i.e., in-process testing) and subsequent release.Oversees process performance qualifications to ensure execution of current GMP during manufacturing, engineering, and production runs for both the drug substance and drug product.Oversee validating and completing all documentation required to introduce new equipment (e.g., SOPs, manufacturing sections of SOWs, White Papers, RFIs, testing protocols, technical reports, batch files, and technical transfer documents). Work with the manufacturing team to review and identify errors in analytical assay reports, qualification/validation documents, and batch records.Ensure the CMO identifies the required vendors, suppliers, and raw materials under FDA/ICH guidance.Review training records of personnel at the CMO to ensure appropriate compliance and competencies. QualificationsNecessary Skills and Knowledge:
Technical knowledge of pharmaceutical manufacturing and an understanding of current GMP.Strong analytical, problem-solving, and organizational skills to balance and prioritize work. Strong interpersonal and communication skills, both oral and written.Minimum Qualifications:
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.Tradeoff Requirement: 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.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.Five (5) years of Industry experience in pharmaceutical/biotechnology advanced development (i.e., IND to FDA approval).Only candidates eligible for a Secret level clearance will be considered (US Citizenship required).Preferred Qualifications:
Active Secret clearance preferred.The salary range for this position is $65,000 to $105,000 per year.
Pay and Benefits
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.
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