Sr. Scientist, Downstream Process Development
About The Position
ProBio, a subsidiary of GenScript, is a global CDMO offering end-to-end services from discovery to GMP for plasmids, antibodies, and cell & gene therapies. We bring together multidisciplinary expertise to accelerate development and manufacturing through customized, and comprehensive services. ProBio has established companies in the United States, the Netherlands, South Korea, and China (Hong Kong, Shanghai, and Nanjing) and other regions to serve global customers, and has helped customers in the United States, Europe, Asia Pacific and other regions obtain more than 150 IND approvals since October 2017. 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.
Requirements
- Master’s or Ph.D. degree with 5+ 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.
- Strong understanding of process scale-up and scale-down modeling.
- Good understanding of Design of Experiment (DOE) and statistical analysis.
- 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.
Nice To Haves
- Experience with LVV and AAV process development is a plus.
- Previous experience in viral vector process development and manufacturing is highly preferred.
- Experience in CMC regulatory affairs for FDA, and EMA is a plus.
Responsibilities
- 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.
Benefits
- medical, dental, and vision insurance
- 401(k) retirement plan with a company match that vests fully on day one
- paid parental leave after just three (3) months of employment
- paid time off policy that includes vacation time, personal time, sick time, floating holidays, and company holidays
- flexible spending and health savings accounts
- life and AD&D insurance
- short- and long-term disability coverage
- legal assistance
- supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
- commuter benefits
- well-being initiatives
- peer-to-peer recognition programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
