Chief Technology Officer (CTO) New
GenScript USA Inc. - Topeka, Kansas, United States
Work at GenScript USA Inc.
Overview
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Overview
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, 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.
Role Description: The Chief Technology Officer (CTO) will play a pivotal role in overseeing Global plasmid and virus, mRNA process development, Manufacturing Science and Technology (MSAT), and clinical and commercial manufacturing processes. Location: CN & US Key Responsibilities: Lead and manage the viral vector process development team, providing scientific, technical, and strategic direction. Drive the strategy for viral vector process development, ensuring alignment with company goals, regulatory requirements, and industry best practices. Foster a culture of innovation, collaboration, and scientific excellence within the team and across the organization. Viral Vector Process Development: Lead and drive the development of viral vector-based manufacturing processes, with a focus on innovation and optimization. Develop strategic plans for plasmid and viral vector process development in alignment with organizational goals and regulatory requirements. Collaborate with cross-functional teams to ensure alignment with project goals and timelines. Lead efforts to optimize plasmid and viral vector production processes to improve efficiency, scalability, and product quality. Manage the transfer of plasmid and viral vector processes from research and development to manufacturing, ensuring seamless integration and compliance with regulatory standards. Design and oversee experiments to evaluate and improve plasmid and viral vector production processes, utilizing statistical methods and experimental design principles. Stay abreast of industry trends and advancements to enhance ProBio's virus-related capabilities. Oversee the planning and execution of clinical manufacturing activities related to plasmid and viral vectors. MSAT and Technology Transfer: Identify and address technical challenges and issues related to plasmid and viral vector production, working closely with cross-functional teams to implement solutions. Facilitate the smooth transfer of plasmid and virus-related processes from development to manufacturing. Work closely with internal and external stakeholders to ensure successful technology transfer. Build and lead a high-performing global team focused on plasmid and viral vector process development and manufacturing. Supervise a team of scientists and engineers engaged in process development activities, providing guidance, mentorship, and fostering a collaborative work environment. Provide mentorship, guidance, and support to team members to foster professional growth. Develop and implement the foundational strategy and change management that is necessary to realize continuous improvement and eliminate process variations. Work collaboratively across the enterprise and externally to strengthen and reinforce a culture of quality, safety and value across ProBio. Build and lead a multidisciplinary quality and safety organization that transcends existing units and reinforces a consistent approach to quality and safety. Create an environment that fosters innovation and performance, supporting the implementation of programs that continuously strengthen the customer experience. Actively implement innovative ideas to redefine, measure and improve quality. Ensure that ProBio rapidly advances as a leader in quality and safety throughout the biotech research industry. Establish quality measurements for internal use and assure reporting of quality metrics to all required external entities, including federal, state, and private. Lead in developing, directing and coordinating innovative quality and outcomes management initiatives across ProBio that incorporate national best practices, drive down variation, decrease costs and create efficiencies. Provides an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork, and supports constructive resolution of conflicts. Encourages workforce engagement by building a commitment to excellence and by promoting the organization's vision internally and externally. Exceeds organizational goals and customer expectations. Makes decisions that produce high-quality results by applying technical knowledge, analyzing problems, and calculating risks. Holds self and others accountable for measurable high-quality, timely, and cost-effective results. Job Requirements: Ph.D. or advanced degree in Biochemistry, Virology and a relevant biological science field with a minimum of 10 years of relevant industrial experience in plasmid and viral vector process development and clinical manufacturing within the biopharmaceutical industry. In-depth knowledge of DNA plasmid, Lentiviral Vectors (LVV), Adeno-Associated Viruses (AAV), and other viral vector technologies. Proven leadership experience with a track record of successfully leading global teams. Strong understanding of cGMP regulations and compliance in a manufacturing environment. Excellent written and verbal communication skills, with the ability to effectively communicate complex technical concepts to diverse audiences. Proven ability to collaborate effectively with cross-functional teams and external partners to achieve common objectives. Ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities and requirements. Strong analytical and problem-solving abilities, with a proactive approach to identifying and resolving technical challenges. #LW 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. Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform. Create a Job Alert Interested in building your career at GenScript/ProBio? Get future opportunities sent straight to your email. Apply for this job
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