Sr. Manufacturing Manager
We are partnering with a leading biotechnology company dedicated to developing and commercializing innovative therapies for patients with chronic and life-threatening conditions. Our mission is to address unmet medical needs and improve the quality of life for those with serious illnesses through groundbreaking treatments.
Position Summary:
We are seeking a highly experienced and dynamic manufacturing leader to join our team. The ideal candidate will have a robust background in cell isolation and a proven track record in managing complex manufacturing processes within the biotechnology or pharmaceutical industry. In this role, you will oversee the production of our cutting-edge therapies, ensuring compliance with regulatory standards, optimizing manufacturing processes, and leading a team of skilled professionals.
Responsibilities
1. Leadership and Management: o Lead, mentor, and develop a high-performing manufacturing team. o Oversee daily manufacturing operations, including scheduling, resource allocation, and workflow optimization. o Foster a culture of continuous improvement and operational excellence within the team. 2. Manufacturing Process Oversight: o Manage the production processes for cell-based therapies, including cell isolation, expansion, and characterization. o Ensure adherence to Good Manufacturing Practices (GMP) and other regulatory requirements. o Develop and implement process improvements to enhance efficiency, yield, and product quality. 3. Quality and Compliance: o Monitor and ensure compliance with all relevant regulations, including FDA, EMA, and other applicable guidelines. o Conduct regular reviews and audits of manufacturing processes and documentation. o Address and resolve any quality issues or deviations in a timely manner. 4. Project Management: o Lead or participate in cross-functional project teams to support the development and commercialization of new products. o Manage project timelines, resources, and budgets to ensure successful project execution. o Collaborate with R&D, quality assurance, and other departments to support product development and scale-up activities. 5. Strategic Planning: o Contribute to the strategic planning and budgeting processes for the manufacturing department. o Identify and implement strategies to optimize manufacturing capabilities and capacity. 6. Documentation and Reporting: o Ensure accurate and timely completion of manufacturing records, reports, and documentation. o Provide regular updates and reports to senior management on manufacturing performance, issues, and initiatives.
Desired Skills and Experience
- Education: Bachelor’s degree in Biotechnology, Biomedical Engineering, Cell Biology, or a related field. Master’s degree or advanced qualification preferred.
- Experience: Minimum of 8-10 years of experience in a manufacturing role within the biotechnology or pharmaceutical industry, with at least 5 years in a leadership or management position. Proven experience in cell isolation and cell-based therapies is required.
- Skills: o Strong knowledge of cell isolation techniques, including but not limited to flow cytometry, magnetic bead separation, and density gradient centrifugation. o Deep understanding of GMP, FDA regulations, and other industry standards. o Excellent leadership, team-building, and interpersonal skills. o Proven ability to manage complex projects and multiple priorities. o Strong problem-solving and analytical skills. o Effective communication skills, both written and verbal.
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