
Bioprocessing Optimization Specialist
1 day ago
Job Description:
We are seeking an experienced Downstream Processing Manager to join our team. The successful candidate will be responsible for leading and managing the downstream processing operations, ensuring compliance with regulatory standards and maintaining high product quality.
The ideal candidate will have a strong background in downstream processing, including separation, purification, and sterile operations. They will have hands-on experience with equipment such as centrifuges, lyophilizers, laminar air flow systems, and clean room operations.
The Downstream Processing Manager will oversee the operation and process control of key equipment, monitor and enhance Overall Equipment Effectiveness (OEE), and manage the calibration of all downstream processing equipment. They will also plan and schedule equipment maintenance to minimize downtime and ensure operational continuity.
Team Leadership & Development:
- Lead, mentor, and develop a team of engineers and technicians, providing crucial technical guidance and support to ensure optimal performance.
- Foster a culture of innovation, collaboration, and continuous improvement within the team and across the department.
Quality & Compliance Management:
- Ensure strict compliance with all relevant regulatory standards and internal quality control procedures.
- Implement robust quality control measures to consistently maintain high product quality.
Operational & Cost Management:
- Monitor and control operational costs to optimize resource utilization and achieve budget targets.
- Proactively identify opportunities for cost reduction without compromising product quality or operational integrity.
Documentation & Reporting:
- Maintain accurate and up-to-date process documentation, standard operating procedures (SOPs), and batch records.
- Prepare clear, concise, and comprehensive technical reports and presentations for various stakeholders.
Required Skills and Qualifications:
- Strong technical understanding of downstream processes, including separation, purification, and sterile operations.
- Hands-on experience with equipment such as centrifuges, lyophilizers, laminar air flow systems, and clean room operations.
- Demonstrated experience with process validation protocols and data analysis.
- In-depth knowledge of regulatory standards including GMP and GLP.
- Excellent leadership, mentoring, and team-building abilities.
- Exceptional communication and interpersonal skills for effective stakeholder management and cross-functional collaboration.
- Proven ability to manage budgets, control costs, and drive operational efficiency.
- Strong organizational skills with an emphasis on documentation and reporting.
Benefits:
Competitive salary and benefits package.
Opportunities for career growth and professional development.
Collaborative and dynamic work environment.
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