Associate Scientist - Production Operation at GenScript

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology

About ProBio

ProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio’s total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, \ProBio has a stable and high-yield viral vector platform.

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.

#LW 

#PB 

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.