Sirnaomics, Inc. is a leading clinical stage biopharmaceutical company in the discovery and development of RNAi therapeutics for treatment of cancer and fibrotic diseases. We are seeking candidates to fill the newly created position of Quality Assurance Manager in our headquarters in Gaithersburg, MD.
The successful candidate will responsible for ensuring that the quality of drugs made by Sirnaomics meet prescribed quality levels so that patient’s safety is essentially protected. Specifically, this person will define quality criteria and quality metrics, and review specific protocol drafts, lab manuals, operation SOPs, etc. to facilitate research development and clinical development; standardize quality processes including test plan development, test documentation, test metrics, best practices, and reporting and visibility for overall quality of our applications; and, educate and train our internal working force as well as collaborating partners.
To be considered for this position, the well qualified candidate will have a Bachelors’ Degree (advanced degree preferred) and 5 or more years of related experience in the bio/pharma industry to include a demonstrated strong understanding of ICH, FDA, NMPA’s principles and requirements on the quality of the therapeutic products, i.e., varied drugs based on siRNA and formulated with nanoparticles. Closely working with R&D, Clinical Study and Manufactory teams to monitor the processes with the emphasize of quality assurance.
Sirnaomics is an Equal Opportunity Employer, and offers a fast paced/dynamic environment, growth opportunity, competitive compensation and a full benefits program.
For consideration, please submit your resume to Talent@Sirnaomics.com.
Only those candidates selected for an interview will be contacted.