Process Development Scientist
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- eupraxiapharma.com
Description
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 may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, also to be applicable in oncology, infectious disease and other critical disease areas.
Eupraxia's EP-104GI is currently in a Phase 1b/2a trial, the RESOLVE trial, for the treatment of 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 trial 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 someone who would like to work for a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who is eligible to work in Canada.
Job Description:
The Process Development Scientist will be responsible for developing manufacturing processes for novel solid and viscous liquid formulations in the Vancouver, Canada laboratory, including responsibilities for process scale-up and tech transfer to contract manufacturing facilities. This is a laboratory-based position, and it is expected that 80% of work time will be spent on-site, rather than working remotely.
Reports to: Director, CMC
Location: Vancouver, BC
Key Responsibilities:
- Design, plan and execute experiments in the Vancouver Laboratory to support the development of novel solid and viscous liquid formulations.
- Develop and/or evaluate appropriate sterilization procedures, including sterile filtration or terminal sterilization by heat and gamma irradiation.
- Scale up manufacturing processes from laboratory to >100L scale for transfer to contract manufacturer sites.
- Engage in technology transfer and production troubleshooting at contact manufacturer sites.
- Identify and procure equipment required for scale-up and for laboratory operations.
- Perform physical characterization of samples as required. Methods may include rheology, viscoelastic analysis, NMR, SEM, and thermal analysis. Ability to operate HPLC/UPLC systems and develop analytical methods is an asset.
- Provide training and supervision to co-op and intern students.
- Interpret and present research findings in a clear, concise manner at company meetings and via written reports.
- Support writing of appropriate sections of regulatory filings, including an IND or IMPD.
- Comply with required Quality Management System procedures, including maintenance of a laboratory notebook.
- Maintain laboratory equipment in a functional status and perform other laboratory duties as needed.
- Assist with CMC group operations as requested.
Additional Attributes:
- Highly self-motivated
- Able to work independently and as part of a study team
- Detail-oriented with a view to the overall scope of the project
- Organized
- Accountable
- Self-directed learner
Requirements:
- At least 5 years of experience in the pharmaceutical industry.
- PhD in chemistry, biochemistry, or pharmaceutical sciences. Candidates with an MSc or a BSc and industry experience will be considered.
- Experience with viscous liquids compounding techniques.
- Experience with sterile filtration and terminal sterilization by autoclave is an asset.
- Experience with aseptic techniques is an asset.
- Knowledge and experience with GMP practices is an asset
- Excellent verbal and written communication skills.
- Ability to multitask and work well in a team, especially in a fast-paced environment.
- A life-long learner mindset.
- A critical thinker.
Salary Range: CAD$120,000 – 130,000 annually
Within the posted range, individual pay is determined by job-related skills, relevant experience, education and/or training. Please note that the range details above reflect the base pay only. A bonus will be available based on performance and remaining in post for the agreed contract duration. We also offer a competitive benefits package.
This is an opportunity to work in a small, entrepreneurial, and highly motivating environment, with a strong emphasis on work/life balance and a supportive company culture.
How to Apply:
Please apply to: https://eupraxiapharma.bamboohr.com/careers/32
While only short-listed candidates will be notified, we thank each applicant for their submission