Associate Scientist - Production Operation

Job Scope:

As an Operation Management Associate Scientist, you will play a critical role in overseeing the production workflow (both pre-clinical/clinical) and ensuring smooth operation from order request to final product delivery. You will be responsible for managing the project, fostering cross-functional collaboration, maintaining quality standards, and implementing continuous improvement initiatives. This role requires to pay attention to details, good project management skills, interpersonal and communication skills with a keen focus on operational excellence.

Responsibilities:

• Operation Management: Coordinate all teams to facilitate work and provide regular feedback and updates to clients/internal team for project progress and conflict resolution, coordinate operations and logistics within R&D, pre-clinical, and clinical GMP manufacturing teams.
• Project Evaluation: Evaluate the project strategy and prepare service proposal based on client’s request and scientific judgment. Develop, maintain, and track detailed and comprehensive project timelines.
• Interpersonal Communication: Establish and maintain effective communication channels with internal stakeholders and senior management. Act as a liaison between the US and CN plasmid business organizations to build and nurture strong relationships.
• Cross-Functional Collaboration: Collaborate with other departments such as PD, QC, QA, GMP Manufacturing, Project Management, Facilities, Supply Chain, and Shipping/Receiving to coordinate production schedules, address issues, and drive continuous improvement efforts.
• Operational Excellence: Drive initiatives to streamline workflows, reduce costs, and enhance the overall effectiveness (productivity, quality, and safety) of Probio's plasmid and viral vector business function.
• Quality Assurance: Implement and maintain quality control measures to ensure that products meet specified standards and requirements. Review documents for accuracy, completeness, and compliance with company’s quality policies.
• Purchase Order Initiation: Receive purchase requisitions from internal departments, verify that purchase orders are properly authorized and compliant with internal controls.
• Equipment Maintenance: Track preventive maintenance and calibration schedules for PD and GMP equipment and machinery to ensure optimal performance and minimize breakdowns. Furthermore, ensure compliance with equipment operating procedures and calibration/maintenance programs in this regard.

Qualifications: 

• Bachelor's degree in life sciences or related field
• 1-3 years of experience in production operation, preferably in a plasmid and/or viral vector PD, MSAT and/or GMP manufacturing environment.
• Commitment to operational excellence and continuous improvement, with a focus on optimizing workflow, processes and driving results.
• Excellent interpersonal and communication skills, with the ability to effectively collaborate and influence stakeholders at all levels of the organization.
• Good understanding of production processes, equipment, and technologies.
• Familiarity with technology transfer, quality management systems and regulatory requirements.
• Strong analytical and problem-solving abilities, with a keen attention to detail and accuracy.
• Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities.

 

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Last updated on Aug 27, 2024