Job description
Nuevocor is a pre-clinical stage biopharmaceutical company dedicated to developing genetic medicines to treat the underlying cause of genetic cardiomyopathies. Backed by an international syndicate of reputable venture capital firms, it will focus on advancing its pipeline of programs to clinical trials. It will also leverage its platform technology, underpinned by a deep understanding of cardiac mechanobiology, to discover and develop therapies for multiple cardiomyopathies.
Nuevocor’s Singapore site is seeking to hire an Analytical Development Scientist to join our Tech Ops department in support of advancing our therapeutic candidates forward. Reporting to the Head of Tech Ops, you will lead analytical development for viral vectors in conjunction with third party vendors or contract development and manufacturing organizations (CDMOs), collaborate with other talented and dedicated scientists, expand your skills in process and analytical development. You will be part of a dynamic and fast-paced biotech working environment.
Responsibilities
· Set up analytical capabilities such as droplet digital PCR, quantitative PCR, immunoassays 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.
· Technical lead for technology transfer and/or assay validation in collaboration with Contract Development and Manufacturing Organizations (CDMOs) for lot release assays or Contract Research Organizations (CROs) for clinical assays.
· 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 departments.
· 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.
Requirements
· A Ph.D. with at least 3 years of experience in a variety of analytical methods. Experience in an industrial setting and CMC analytical environment is an advantage. Candidates with more years of relevant experience will be considered for a title commensurate with experience.
· Hands-on experience with analytical methods such as immunoassays, 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.
· High standards in documentation and record keeping.
· Demonstrated ability working both independently and in teams.
· Good time management and pro-active attitude.
· 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.
Interested candidates, please submit a CV and cover letter to http://tinyurl.com/nuevocorcareer
