Senior Director of Reagent Production for Molecular Diagnostics

Responsabilités

The Molecular Diagnostic Manager plays a pivotal role in overseeing the development, production, and quality control of reagents for molecular diagnostic assays, ensuring adherence to regulatory standards and operational excellence. This position requires a strong background in molecular biology, biochemistry, or a related field, along with extensive experience in diagnostic assay development and manufacturing processes. The successful candidate will be responsible for leading a team of scientists and technicians, managing project timelines, and maintaining compliance with Good Manufacturing Practices (GMP) and other relevant regulatory guidelines. Additionally, they will collaborate with cross-functional teams to drive innovation, optimize manufacturing workflows, and ensure the timely delivery of high-quality diagnostic products to market. Microseism Scientific, a distinguished provider of high-quality medical supplies, seeks a detail-oriented professional to support its growing operations. The ideal candidate must possess a degree in a relevant scientific field, such as Biochemistry or Microbiology, along with hands-on laboratory experience. Proficiency in equipment operation, data recording, and inventory management is essential, as is the ability to adhere to stringent quality control protocols. Additionally, strong communication skills are required to collaborate effectively with cross-functional teams and ensure seamless workflow coordination. Plot 16 A-C at Martyrs Way, Linda is a prime residential address within a sought-after neighborhood, characterized by its convenient proximity to key amenities. The property boasts a well-maintained structure and offers ample living space, making it ideal for families or professionals seeking comfort and accessibility. Prospective residents will appreciate the secure environment, modern infrastructure, and vibrant community atmosphere that define this sought-after location. We seek a highly motivated individual to join our team in Kampala, Uganda, where they will contribute to impactful projects and foster sustainable development initiatives across the region. The ideal candidate will possess a strong academic background in a relevant field, such as international development, economics, or social sciences, coupled with professional experience in project management or related areas. Fluency in both English and a local language, such as Luganda, is essential, along with exceptional communication and interpersonal skills to engage effectively with diverse stakeholders. The role demands adaptability to dynamic environments, a commitment to ethical practices, and the ability to work collaboratively in multidisciplinary teams. Responsibilities include designing and implementing programs, conducting needs assessments, monitoring progress, and reporting outcomes to ensure alignment with organizational goals. Healthcare professionals deliver essential medical services to patients, diagnosing illnesses, administering treatments, and providing preventive care to promote overall well-being. They operate in diverse settings, including hospitals, clinics, and private practices, often collaborating with multidisciplinary teams to ensure comprehensive patient care. Strong communication skills, attention to detail, and the ability to work under pressure are critical for success in this field. Additionally, practitioners must adhere to ethical standards, maintain patient confidentiality, and stay current with advancements in medical research and technology. Science, Engineering, and Management professionals are responsible for overseeing manufacturing and warehouse operations while ensuring seamless business operations. They manage workflows, optimize production processes, and implement strategic initiatives to enhance efficiency and productivity. These roles require strong leadership, analytical skills, and a deep understanding of operational logistics to drive continuous improvement and meet organizational objectives. Candidates must possess relevant experience in production management, supply chain coordination, and business strategy development to excel in these positions. Background information about the job or company (e.g., role context, company overview) Microseism is in search of a seasoned Molecular Diagnostic Manager to oversee the comprehensive manufacturing process of molecular diagnostic reagents. The successful applicant will possess advanced technical knowledge, demonstrated leadership in process scale-up, and comprehensive expertise in GMP and ISO 13485 standards to deliver high-quality, globally competitive products. Oversee a wide range of duties encompassing strategic planning, project execution, and team leadership to ensure organizational objectives are met efficiently and effectively. Collaborate with cross-functional departments to streamline processes, enhance productivity, and foster innovation across all operational areas. Develop and implement policies, procedures, and performance metrics to maintain high standards of quality, compliance, and accountability. Monitor progress through regular assessments, providing constructive feedback and identifying opportunities for continuous improvement. Manage resources, budgets, and timelines while mitigating risks to achieve project goals within stipulated constraints. Ensure adherence to industry regulations, safety protocols, and ethical standards to uphold the organization’s reputation and operational integrity. Leads the day-to-day operations of molecular diagnostic production, ensuring adherence to quality standards and regulatory requirements. To uphold stringent adherence to Good Manufacturing Practices (GMP), ISO 13485 standards, established Standard Operating Procedures (SOPs), and comprehensive quality assurance protocols. Supervise and train production personnel, ensuring adherence to operational standards while fostering a skilled and efficient workforce. Develop and execute manpower allocation strategies to optimize productivity and align with project demands. Responsible for managing batch production records, associated documentation, and Corrective and Preventive Action (CAPA) processes to ensure compliance and operational efficiency. Monitor equipment to ensure optimal performance, proper calibration, and adherence to preventive maintenance schedules, identifying and addressing any deviations or inefficiencies promptly.

Spearhead workflow optimization initiatives and foster ongoing process enhancements to boost efficiency and productivity across operations. Lead the transition of production from pilot-scale to commercial-scale batches, guaranteeing consistency and adherence to regulatory standards throughout the process. We will develop and deploy electronic batch records systems while ensuring seamless integration with Laboratory Information Management Systems (LIES) to enhance operational efficiency and compliance. We assist in meeting incoming, ongoing, and final quality control testing needs for both open and closed molecular systems. All production-related activities must be meticulously recorded in accordance with ISO 13485 and/or WHO TGS/TSS standards to ensure full regulatory compliance. Engage actively in the validation and verification of methodologies, as well as contribute to technology development and transfer initiatives. Identify opportunities to streamline processes and reduce costs while maintaining reagent quality and integrity. Ensure standard operating procedures (SOPs) and batch records are established and maintained consistently to uphold compliance and operational standards. We will manage the design and implementation of performance evaluation studies, encompassing both analytical and clinical dimensions. Champion contamination control strategies, including clean room zoning and environmental monitoring, to ensure adherence to stringent quality and safety standards. We collaborate efficiently with R&D, QA, QC, and regulatory teams to facilitate the development and introduction of new products. Responsibilities include conducting training sessions for junior production personnel to ensure competency in GMP/ISO 13485-compliant molecular reagent production techniques and adherence to GMP principles. The ideal candidate must meet specific educational credentials and possess a range of technical and soft skills to excel in this role. A bachelor’s degree in a relevant field is required, along with proficiency in industry-standard software and tools. Prior experience in a similar position is essential, and familiarity with key processes or systems is highly valued. Strong problem-solving abilities, exceptional communication skills, and the capacity to work independently are also necessary. Additionally, the ability to manage multiple priorities and meet deadlines in a fast-paced environment is crucial. A Bachelor’s or Master’s degree in Molecular Biology, Biotechnology, Biochemistry, or a related discipline is strongly preferred for this role. To be considered for this role, candidates must possess a minimum of five years of practical experience in molecular diagnostic production within a manufacturing environment that adheres to GMP and ISO 13485 standards.

Expérience

• A minimum of three years of leadership experience overseeing teams in molecular reagent production is required. With a demonstrated history of successfully expanding molecular diagnostic reagent manufacturing operations while maintaining full compliance with GMP and ISO 13485 standards. With a minimum of five years of experience in molecular diagnostics manufacturing, including at least four years in a leadership role within GMP/ISO 13485-compliant environments, the ideal candidate will bring extensive expertise to this position. Experienced professionals are required for this role.

---

**

[Click the Apply button below to apply, and Create my CV to build a CV tailored to this offer, professionally]