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/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.
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What We Do
Founded in 2002 and listed on the Hong Kong Stock Exchange in 2015, GenScript has an established global presence across Greater China, North America, the EU, and Asia Pacific. Today, over 300,000 customers from over 160 countries and regions worldwide have used GenScript’s premier, convenient, and reliable products and services. GenScript currently has over 5,000 employees globally, 33% holding master’s and/or Ph.D. degrees. In addition, GenScript has a number of leading commercial technologies developed in the fields of synthetic biology, immunotherapy, antibody design, chemical synthesis, and bioinformatics, including more than 100 patents and over 270 patent applications. As of June 2022, GenScript's products and services have been cited by 74,700 scientific papers worldwide. GenScript is committed to striving toward its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.
