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Manager of Technical Operations in MS&T
2 months ago
Job Overview:
As a pivotal role within the Healthcare Businesswomen's Association, the Technical Manager in Manufacturing Science and Technology (MS&T) serves as the primary technical liaison between the organization and its external partners. This position requires a deep understanding of manufacturing and packaging process design, validation, and the resolution of technical challenges.
Key Responsibilities:
- Technical Liaison: Foster strong partnerships with external suppliers to enhance product process capabilities and ensure that manufacturing processes remain up-to-date and validated.
- Product Oversight: Act as the Single Point of Contact (SPOC) for key molecules, maintaining comprehensive knowledge of the manufacturing processes throughout the product lifecycle.
- Data Analysis: Analyze manufacturing data to assess product quality and process robustness, ensuring compliance with critical quality attributes (CQAs) and process parameters.
- Change Management: Evaluate the impact of technical changes and lead root cause investigations for product and process failures, collaborating with cross-functional teams.
- Validation Management: Oversee validation processes to maintain products in a constant state of validation, ensuring that all technical batches generate necessary process knowledge.
- Product Launch and Transfer: Participate in the evaluation and selection of external suppliers, providing essential technical information for product transfers and launches.
- Development Collaboration: Work closely with development teams to ensure that new products are designed for commercial scalability and meet all regulatory requirements.
- Manufacturing Excellence: Lead optimization projects to enhance process robustness and sustainability, leveraging subject matter expertise in pharmaceutical processes.
Performance Metrics:
Success in this role is measured by the reliability of assigned products, the robustness of manufacturing processes, and the timely execution of technical reports.
Qualifications:
Candidates should possess a strong background in operations management, project management, and technical oversight, with skills in applied statistics, risk management, and process validation.
Language Proficiency:
Fluency in English is required.