Analytical Development Scientist
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 analytical capabilities in the CMC lab such as droplet digital PCR, quantitative PCR, flow cytometry and cell-based assays
- Conduct experiments to develop, optimize and qualify analytical methods for in-process controls, lot release and characterization of drug product
- Perform quantitative analysis of experimental data using statistical approaches and software such as JMP
- Participate in technology transfer and assay validation 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 analytical methods to support regulatory agency submissions
- Author relevant CMC sections for regulatory filing
- Identify, evaluate and implement new technologies to improve existing methods or to perform deep phenotyping of drug product
- 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 analytical methods
- 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**:
- Hands-on experience with analytical methods such as flow cytometry, cell-based assays, protein and nucleic acid analysis
- Working knowledge of critical elements and relevant guidelines (e.g. ICH Q2(R1)) for consideration during the validation of analytical procedures for potency, purity, identity
- 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$9k monthly. There will be a 13th month bonus, yearly performance bonus, health insurance and flexible benefits.
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