Vela is a recently incorporated Molecular in vitro Diagnostics Company with Research and Development facilities in Singapore and the United States (Fairfield, NJ). Vela Research Singapore is focused on the development and commercial distribution of IVD molecular tests in the field of Oncology, Pharmacogenetics, Microbiology and Infectious Diseases. Vela’s Management team consists of industry veterans.
Director R&D Oncology, Singapore
Vela is recruiting for its Singapore site a Director R&D Oncology, for its PCR test development program.
Title: Director R&D Oncology, Singapore
Reports To: SVP / Global Head R&D, Singapore
Company: Vela Research, Pte. Ltd.
Roles and responsibilities:
A) Development of innovative products for PCR based in vitro diagnostic platform
B) Management of product development process
C) Lead team of up to 10 scientists and research officers
D) Full accountability for development of assigned products including specifications, budget & timelines
E) Help establish and follow SOP development guidelines as well as adherence to CE/IVD and FDA regulations and guidelines
F) Product maintenance and product technology evaluation
G) Evaluation of competitive methods
H) Market trends analysis and needs development
I) Support set-up, operation and expansion of R&D facility in Singapore
J) Support preparation and submission of all documentation required by regulatory authorities for commercialization
K) Alignment of activities with the Vela Head of Regulatory Affairs
Requirements and qualifications:
A) Minimum of 7 years of R&D experience, with a minimum of 3 years in PCR test development
B) Proven track record of successful product development and transfer to a production environment in an ISO 13485 or FDA/GMP environment
C) Relevant scientific degree; MS or equivalent required, PhD strongly preferred
D) Expertise in Molecular Diagnostics, Oncology
E) Leadership experience preferred
Location: Singapore; travel may be required from time to time
Contact: human.resources@veladx.com
Only shortlisted candidates will be notified.
