Downstream Process Development
3 days ago
**Job description**
Nuevocor is a pre-clinical stage biopharmaceutical start-up dedicated to developing gene therapies to treat the underlying cause of genetic cardiomyopathies. Backed by an international syndicate of reputable venture capital firms, it will focus on advancing its lead program to clinical trials. It will also leverage its platform technology, underpinned by a deep understanding of cardiac cell biology and novel cardiotropic viral vectors, to discover and develop therapies for genetic cardiomyopathies.
**How you will achieve it**
- Set up downstream process development capabilities in the CMC lab such as single-use bioreactors and upstream analytical instruments
- Envision and execute the harvest, chromatography and filtration development strategies and technologies to advance adeno-associated virus (AAV) purification and scale-up
- Perform quantitative analysis of experimental data using statistical approaches and software such as JMP
- Participate in process development activities and technology transfer in collaboration with Contract Development and Manufacturing Organizations (CDMOs)
- Prepare high quality documents including standard operating procedures (SOP), technical memorandums and reports related to the upstream process to support regulatory agency submissions
- Author relevant CMC sections for regulatory filing
- Identify, evaluate and implement new technologies to improve purification strategies and increase viral vector yield
- Collaborate with other research groups to advance Nuevocor’s clinical pipeline
- Update Electronic Lab Notebook with experimental procedures, results and conclusions in a timely manner
- Comply to local and site wide EHS and biosafety requirements and function as Risk Assessment leader for new downstream process methodology
- Support and participate in daily laboratory operations and maintenance
- Mentor and train junior scientists to support their career growth and success in the lab
**To succeed in this role, you will have**:
- Strong hands-on experience in downstream process development of viral vectors using chromatography (e.g. affinity, ion-exchange, multi-modal) and filtration (e.g. tangential flow filtration) technologies
- Ability to independently lead development and optimization activities to enable a high productivity, scalable and robust in-house viral vector downstream process
- Demonstrated ability working both independently and on teams
- Strong problem-solving skills
- Excellent interpersonal and communication skills (written and oral)
- A positive, can-do attitude and flexibility to support other activities within Nuevocor
- Keen interest in working in a fast-paced, start-up environment
Nuevocor is an equal opportunity and equal benefits employer. All qualified applicants will receive consideration for employment. Position is commensurate with experience. Expected salary range S$6 - S$11K monthly. There will be a 13th month bonus, yearly performance bonus, health insurance and flexible benefits.
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