Sr. Manager of Analytical Development

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 GenScript ProBio

GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing 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. GenScript 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, GenScript 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, GenScript ProBio has a stable and high-yield viral vector platform.

Overview:

The role of Analytical Development Head is crucial in ensuring the quality, compliance, and efficiency of analytical operations within a scientific organization. It requires strong leadership, technical expertise, and the ability to collaborate effectively across departments and with external partners.

Responsibilities:

• Develop and execute the analytical development strategy aligned with organizational goals.
• Provide leadership and guidance to the analytical development team.
• Drive innovation in analytical methodologies and technologies.
• Recruit, train, and develop a high-performing team of analytical scientists.
• Foster a collaborative and supportive team environment.
• Set clear goals and objectives for team members and provide regular feedback.
• Oversee the development, optimization, and tech transfer of analytical methods of plasmid and viral vector
• Setting strategy for evaluating and implementing new technologies within the Analytical Development department
• Communicate with development SME and lead assist in method remediation/trouble shooting
• Perform analytical characterization of therapeutic AAV and plasmids and lead method transfer to QC teams;
• Identify AD related risks associated with Projects and propose risk mitigation measures. Escalate the risks to management.
• Authorize or review electronic notebook, SOPs and study reports
• Develop new techniques to expand the analytical capacity
• Coordinate activities with manufacturing, discovery and external contract organizations
• Develop analytical methods that are accurate, precise, specific, and robust
• Reviews analytical chemistry testing records of raw materials, stability, and product for accuracy and adherence to test methods
• Ensure analytical methods and procedures meet regulatory guidelines (FDA, EMA, etc.).
• Support regulatory submissions by providing analytical data and documentation.
• Participate in regulatory inspections and audits as needed.
• Identify opportunities for process optimization and efficiency improvements.
• Implement best practices in analytical development and quality control.
• Stay current with industry trends and advancements in analytical techniques.
• Communicate analytical strategies, progress, and issues to senior management and stakeholders.
• Collaborate with external partners, customers, and academic institutions as needed.

Qualifications:

• Education: Advanced degree (Ph.D. or Master's) in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, or related field.
• Experience: Several years of industrial experience (Level depends on experience) in analytical development within the pharmaceutical or biotechnology industry, including supervisory or managerial roles. Strong leadership and team-building skills. Expertise in analytical method development, validation, and troubleshooting in plasmid, viral vector, cell and gene therapy field. Knowledge of regulatory requirements and guidelines (FDA, ICH, etc.). Excellent communication and interpersonal skills. Ability to manage multiple projects and priorities effectively.

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