Process Development Scientist

About Us:

Eupraxia is a clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. DiffuSphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the DiffuSphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia's DiffuSphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas extend beyond pain and inflammatory gastrointestinal disease, where Eupraxia is currently developing advanced treatments, to applications in oncology, infectious disease and other critical disease areas.

Eupraxia's EP-104GI is currently in a Phase 1b/2 trial (RESOLVE) for the treatment of eosinophilic esophagitis (EoE). EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also recently completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The SPRINGBOARD trial successfully met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com.

We are looking for people who would like to work in a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who are eligible to work in Canada.

Job Description:

Role Summary

The Process Development Scientist will be responsible for developing and overseeing manufacturing processes for our DiffuSphere formulations at our contract manufacturing sites, including responsibilities for process scale up and optimization.

Reports to: Director, CMC

Key Responsibilities

• Oversee process scale up and optimization activities at our contract manufacturing sites for later stage clinical products and provide technical direction as required.
• Actively participate in production troubleshooting at all scales and be a “person-in-plant".
• Manage CDMO interactions and technical communications.
• Oversee that all manufacturing processes meet cGMP requirements for both US and EU.
• Identify and procure equipment required for scale-up and optimization operations, both in house and at CDMOs.
• Perform physical characterization of samples as required. Methods may include, optical microscopy, SEM, NMR, thermal analysis, rheology
• Effectively communicate, in written and verbal form, any interpreted research findings.
• Support writing of scientific and production reports, and the appropriate sections of regulatory filings including an IND or IMPD.
• Assist with CMC group operations as requested.

 Requirements

• Minimum of 8-10 years experience in the pharmaceutical industry.
• PhD in chemistry, biochemistry, or pharmaceutical sciences. Candidates with MSc or BSc and considerable industry experience may be considered.
• Experience with recrystallization, wet milling and sieving required to provide technical direction when needed.
• Experience with GMP compliance in US and EU mandatory.
• Excellent verbal and written communication skills.
• Must have the ability to multi-task in a dynamic environment and work well within a team.
• A life-long learner mind set.
• A critical thinker.

Salary Range: $120,000 to $140,000 depending on education and relevant experience.