Aquinox is a clinical-stage pharmaceutical company discovering and developing targeted therapeutics in disease areas of inflammation and immuno-oncology. Our primary focus is anti-inflammatory product candidates targeting SH2-containing inositol-5′-phosphatase 1, or SHIP1, which is a key regulator of an important cellular signaling pathway in immune cells, known as the PI3K pathway. Our lead product candidate, AQX-1125, is a small molecule activator of SHIP1 suitable for oral, once daily dosing. Having successfully completed multiple preclinical studies and seven clinical trials with AQX-1125, we are now advancing towards pivotal Phase 3 trials with AQX-1125 in our lead indication of bladder pain syndrome / interstitial cystitis (BPS/IC). Aquinox has a broad intellectual property portfolio and pipeline of preclinical drug candidates that activate SHIP1.
Aquinox is publicly traded on NASDAQ and has offices in Vancouver, BC and in the San Francisco, CA area.
Reporting to the Director, Pharmaceutical Development and based in our Vancouver office, the Scientist will provide analytical direction, oversight and review of Contract Research and Manufacturing Organizations for the development and release of drug substance and drug product and will provide bioanalytical expertise and support for clinical and non-clinical studies. Specifically, the Scientist will:
- Work closely with Contract Research and Manufacturing Organizations in a variety of countries to develop, establish and validate methods used to control and release raw materials, intermediates, drug substance and final product for AQX-1125 in accordance with cGMP; review and approve reports
- Review and approve stability programs and reports
- Provide technical direction and support for bioanalytical method development and validation and bioanalysis of samples from clinical and non-clinical studies including the review of methods development data, validation protocols and reports, and bioanalysis of study samples
- Draft and review documents for CMC sections of regulatory submissions, for example, INDs, IMPDs and NDAs
- Support the development of next generation compounds
- MSc in Analytical Chemistry with minimum of 5 years experience in the pharmaceutical industry or PhD in Analytical Chemistry with minimum of 3 years of relevant experience in the pharmaceutical industry
- Experience using analytical techniques and instrumentation, such as gas and high performance liquid chromatography (HPLC) and mass spectrometry required
- Experience with analytical methods development and validation for pharmaceutical products required
- Working knowledge of cGMP and regulatory guidances as they relate to analytical topics such as method validation, impurities and stability testing required
- Experience interacting with CROs and/or CMOs highly desirable
- Strong computer skills in the use of Excel, Word, PowerPoint
- Demonstrated initiative and results orientation
- Strong written and oral communication skills
- Ability to multitask and collaborate in a busy team-oriented work environment
- Creative problem solver with the ability to address issues quickly independently, balanced with judgement to escalate issues as needed
- Strong attention to detail and dedication to accurate and high-quality work
Our current clinical trials, exceptional team, and strong track record make it an excellent time to seize this exciting opportunity.
Interested candidates are invited to forward their resume and cover letter to firstname.lastname@example.org, indicating why you feel you are a fit for the Scientist, Analytical Chemistry role at Aquinox Pharmaceuticals, Inc.
We thank all applicants for their interest; only those chosen for an interview will be contacted.