Sr). Scientist, Downstream Process Development

Position: (Sr). Scientist, Downstream Process Development
About Gen Script
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 Pro Bio
Pro Bio 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. Pro Bio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.

Position Overview:

The position reports to the Associate Director, Downstream Viral Vector Process Development & MSAT Department. This role is ideally suited for a dynamic bench-focused individual to support/lead translation of research process to GMP-compliant manufacturing, and will develop, scale-up, and evaluate the technology transfer of viral vector processes. This is a great opportunity to join a fast-paced company, develop, and expand technical expertise to lead by example and potentially lead a small team in the near future.

• Hands-on experimental work in the development and optimization of downstream unit operations (TFF, Affinity/Ion Exchange/multimodal Chromatography, Viral clearance, Sterile filtration, etc.) for viral vector manufacturing process.
• Contribute to the planning, design, and execution of AAV/LVV purification-related experiments to analyze, interpret, and report data summary packages.
• Interact and collaborate with internal/external partnerships to evaluate and implement new bioprocessing technologies and strategies.
• Interact with cross functional teams (Analytic team, MFG, Supply chain, Facility, QA, QC) to support process technology transfer, cGMP risk evaluation, and deviation management.
• Maintain and follow detailed and comprehensive project timelines.
• Support in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.
• Present updates to project or upper management teams on process development and manufacturing support activities.
• Read and understand scientific literature in gene and cell therapy. Use the knowledge to generate ideas and contribute to process design and development.
• Perform other duties as assigned based on business needs.

Qualifications:

• Bachelor's degree with 3-7 years, or Master's or Ph.D. degree with 1-3 years' relevant industry experience in Chemical/Biochemical Engineering, Biological Sciences, or a related scientific discipline in biotech development with particular experience in gene and cell therapy product design. Experience with LVV and AAV process development is a plus.
• Previous experience in viral vector process development and manufacturing is highly preferred.
• Strong understanding of process scale-up and scale-down modeling.
• Good understanding of Design of Experiment (DOE) and statistical analysis.
• Experience in CMC regulatory affairs for FDA, and EMA is a plus.
• Strong organizational skills and detailed documentation abilities are required.
• Work independently in hands-on laboratory setting, self-motivated to learn and develop new techniques.
• Strong interpersonal, verbal, and written communication skills.
• Results oriented, be able to effectively prioritize and complete tasks on time.
• Collaboration and teamwork.
• Must be comfortable in a fast-paced, multi-tasking biotech environment.

Compensation: The salary range, dependent upon experience level, is $80,000 - $110,000 annually.

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GenScript USA Inc/Pro Bio Inc. is a proud equal opportunity/affirmative action employer committed…