What are the responsibilities and job description for the (Sr.) Scientist, Downstream Process Development & MSAT position at GenScript/ProBio?
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 ProBioProBio 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:
The position reports to the Head of 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.
Roles and Responsibilities:
- Hands-on experimental work in the development and optimization of downstream unit operations (TFF, Affinity/Anion Exchange Chromatography, Viral clearance, 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 leads (Manufacturing, 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.
- 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 Oncolytic, Lenti, AAV process development for oncology 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 is 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.
- Must be comfortable in a fast-paced, multi-tasking biotech environment.
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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.
Salary : $92,400 - $126,200
