Director, CMC

Director, CMC

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: 

This position is responsible for managing all technical operations for the supply of existing and new sustained-release drug products (polymer drug delivery systems), including manufacturing, manufacturing process development, formulation development, analytical and stability testing, and quality control. The Director will oversee and direct all external vendors hired to implement technical operations.

This position requires direct internal and external hands-on management and participation in manufacturing and process-development activities.

Reports to: VP, CMC

Key Responsibilities:

• Implement the overall strategy for scale-up and optimization at our contract manufacturers.
• Provide guidance to external vendors on plans for optimization of the manufacturing process.
• Ensure manufacturing processes meet GMP requirements for the US and EU at a minimum.
• Manage fundamental functions such as production planning and scheduling, inventory management, physical distribution, warehousing, labelling and packaging.
• Critically review manufacturing documents, including Batch Records, raw data, analytical methods, validation protocols and specifications.
• Approve reports including Deviations, OOS, and Corrective and Preventive Actions (CAPAs).
• Manage CMC budget and operating expenses on a quarterly basis.
• Routinely present updates on progress at team meetings and corporate presentations.
• Write key sections of regulatory documents, including IND and IMPD.

Preferred Qualifications and Expertise:

• 15 years of experience in the pharmaceutical industry.
• At least 5 years in a leadership position.
• PhD in a relevant scientific discipline. Strong candidates with MSc or BSc with sufficient experience will be considered.
• Experience with crystallization, spray drying, Fluid Bed coating systems, polymers and films is an asset.
• Knowledge of materials characterization techniques, including but not limited to: NMR, FTIR, TGA/DSC, fluorescence microscopy, XRD.
• Experience with Analytical Chemistry techniques, including HPLC, GPC, and USP dissolution systems, is an asset.
• Excellent verbal and written communication skills.
• Ability to multitask and work well in a team, especially in a fast-paced environment.
• Knowledge and experience with GMP practices, ICH, FDA, and USP.

Additional attributes:

• Highly self-motivated
• Able to work independently and as part of a study team
• A lifelong learner mindset
• A critical thinker
• Organized
• Accountable

 Salary Range:  CAD$ 190,000 – 210,000 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 upon performance and remaining in post for the agreed contract duration. We also have a competitive benefits package on offer.

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 send your CV and cover letter to careers@eupraxiapharma.com .