Careers

 

At Eupraxia, we dream of a world where we can make a difference to patients and their families. Of a workplace that inspires innovation and fosters work/life balance. Where creative people roll up their sleeves to solve the problems that really matter and transform the impossible into the inevitable.

We look for professional like-minded individuals that are willing to bring something new to our team. If you are interested in joining us, send an email to careers at eupraxiapharma.com.

Current opportunities:

 

Clinical Study Manager

Job Description:

Eupraxia Pharmaceuticals is an early stage life sciences company taking the exciting next step in its growth. This requires us to have an independent and experienced Clinical Study Manager (CSM) join our team.

Reporting to the Senior Director, Clinical Science & Operations, the CSM will oversee the design, planning, implementation, analysis and reporting of assigned clinical studies. The CSM oversees contracted vendors to ensure compliance with the study budget, project scope and timelines while complying with applicable standard operating procedures (SOPs), Good Clinical Practices (GCP), regulatory and study-specific requirements.

This is a full-time position and can be home or office-based, preferably in Victoria/Vancouver BC, Canada. Some travel will be required.

Key Responsibilities

  • Serves as Eupraxia’s primary clinical study contact and is responsible for management and oversight of vendors
  • Plans activities and resources (e.g. internal and external resources, equipment etc.) required for assigned studies
  • Manages study related budgets
  • In collaboration with Outsourcing Clinical and Quality Assurance departments, supports the identification, qualification, selection and contracting process for clinical study vendors
  • Ensures delivery of key clinical study milestones in compliance with the agreed study budget, project scope and timelines and in accordance with applicable SOPs, GCP, regulatory and study-specific requirements
  • Provides regular status updates to internal stakeholders
  • Inputs, reviews and coordinates Eupraxia’s team review of study-specific documents (e.g. protocol, protocol amendments, informed consent, electronic case report form (eCRF), tables, listings figures (TLFs), clinical study report, etc.)
  • Develops, reviews and coordinates Eupraxia’s team review of clinical project operational plans and manuals as applicable (e.g., project management plan, monitoring plan, etc.)
  • Oversees activities related to site selection (feasibility questionnaires, sites selection, planning of site qualification visits) and patient recruitment (monitors patient recruitment status, follows-up on recruitment strategy plan)
  • Oversees activities related to central ethics submissions.
  • Ensures contracted vendors collect required essential documents from sites prior to study initiation.
  • Participates in the planning and execution of Investigator’s Meetings and Site Initiation Visits
  • Oversees contracted vendor’s performance of clinical monitoring activities for site qualification, initiation, routine and close-out visits. Reviews monitoring visit reports and site visit follow-up letters, performs co-monitoring visits as necessary
  • Ensures that the Trial Master File (TMF) is complete and accurate.

Requirements

  • BSc. in a related life-sciences discipline
  • 5 years clinical research experience in the biotechnology/pharmaceutical industry
  • Experience successfully managing clinical study scope. deliverables, and timelines including capability with data analysis, report and protocol writing
  • Demonstrated knowledge of GCP and ICH standards, FDA and Canadian regulations
  • Exceptional project & time management skills including budgeting, scheduling, risk management and project tracking coupled with the proven ability to multi-task
  • Excellent interpersonal skills and a demonstrated ability to influence within the wider project team at the level of functional leadership
  • An effective self-manager with the ability to work independently and in a small team environment
  • Demonstrated success with building effective working relationships with colleagues and vendors
  • Critical thinker with good problem-solving abilities
  • Strong ability to carry out different projects and work under pressure in a composed manner when dealing with issues, challenges and conflicts
  • Embraces process simplification and/or continuous improvement managing any change effectively
  • Innovative thinker willing to take measured risks within the bounds of compliance to achieve clinical success
  • Excellent knowledge of Microsoft Office suite, including MS Project (or similar project planning tools).

 How to Apply:

  • Please send your cover letter and resume to careers@eupraxiapharma.com with job code: CO0527 in the header.

    While only short-listed candidates will be notified, we thank each applicant for their submission.

Director, Analytical Development/ Chemistry

Job Description:

Eupraxia Pharmaceuticals is an early stage life sciences company taking the exciting next step in its growth. This requires us to have an independent and experienced Director, Analytical Development / Chemistry join our team.

Reporting to the Vice President of Chemistry and Manufacturing Controls (CMC), the Director, Analytical Development / Chemistry will lead all aspects of analytical development from research through clinical trials and submission of regulatory documentation for IND’s, CTA’s, NDA’s and MAA’s. This requires knowledge of all appropriate regulatory guidances and requirements for Eupraxia products and manufacturing processes. This position is also responsible for the formulation of appropriate departmental strategic planning and the establishment and management of external relationships to support the analytical development function.

This is a full-time position to be based in either Victoria or Vancouver BC, Canada. Travel of ~10% will be required.

Key Responsibilities

  • Lead all aspects of analytical development for new Eupraxia products from the research stage through to product registration
  • Build internal analytical capabilities at our new research facility in Vancouver, BC and manage internal analytical staff
  • Select and manage external analytical resources at manufacturers and CRO’s
  • Formulate and execute all analytical development strategies
  • Support the development and validation of analytical methods internally or at external vendors
  • Design test methods to assess product quality attributes and establishment specifications
  • Review and present key analytical data to internal staff and management
  • Stay updated on all existing and new analytical regulatory guidances and adjust plans to ensure compliance
  • Establish and maintain a strong working relationship with Quality Assurance staff, internally and externally

Requirements

  • Minimum M.Sc. in chemistry or analytical chemistry with 10-15 years of analytical chemistry experience in the pharmaceutical industry
  • Experience with analytical methodologies including but not limited to: HPLC, GC, in-vitro release, particle sizing, thermal analysis, viscosity, container closure integrity, extractables and leachables testing, bioburden, sterility, and endotoxins
  • Proven track record with virtual drug development and working extensively with external vendors to develop and validate analytical methods
  • Extensive experience and knowledge of US, European, and Canadian regulatory requirements for parenteral drug products
  • Demonstrated people skills and success building effective technical teams
  • Experience with writing and reviewing CMC sections of regulatory documents
  • Solid understanding of drug product manufacturing operations and the application of analytical techniques
  • Strong experience with the product development process across a pharmaceutical organization
  • Proven success with analytical development regulatory submissions and approvals (IND/CTA and NDA/MAA)
  • Strong written and oral communications
  • Strong problem-solving skills and the ability to manage on multiple projects
  • Effective team building, team participation and dependability
  • Good organization and decision-making abilities

 How to Apply:

  • Please send your cover letter and resume to careers@eupraxiapharma.com with job code: CMC0527 in the header.

    While only short-listed candidates will be notified, we thank each applicant for their submission.

Analytical Associate

Job Description:

To support our R&D and product development activities, we have an immediate opening for an Analytical Associate with our Research and Development group in the Vancouver, Canada office.

The successful candidate will be responsible for method development, in-house analyses in support of developing technologies and working directly with our vendors. The candidate will be expected to work both independently and supervised to perform and document analytical activities, as well as novel in house developed methods. In addition, the Analytical Associate will contribute to the general functioning of the R&D laboratory, qualifying and maintaining laboratory equipment, and drafting development reports and methods according to company standards.

It is also expected that the Analytical Associate will additionally contribute to formulation development when required

Key Responsibilities

  • Perform a variety of lab procedures for chemical, physical and biological characterization of materials; calibrate equipment available as required
  • Perform analytical characterization methods; interpret results and prepare data summaries
  • Present findings and recommendations at R&D and CMC meetings
  • Demonstrate commitment to continual learning of laboratory techniques and products
  • Troubleshoot standard experiments and contribute to scientific discussions
  • Assist with maintaining the lab as requested (e.g. inventory of supplies, waste disposal, safety measures)
  • Assist with department operations as requested (e.g. filing reports, data management)
  • Comply with required QMS procedures including maintenance of a signed laboratory notebook

Requirements

  • A BSc degree in chemistry, biochemistry, or related field: MSc is an asset. Candidates with proven experience are also encouraged to apply
  • Experience with organic synthesis, conjugation, polymers, organic crystal growth is an asset
  • Knowledge of materials characterization and analytical chemistry techniques including but not limited to: HPLC, GC, Dissolution (IVR), NMR, FTIR, TGA/DSC, UV-Vis spectroscopy, fluorescence microscopy, XRD
  • Knowledge of biological systems would be an asset
  • Excellent verbal and written communication skills
  • Ability to multi-task, be organised and work well in a team, specially a fast pace environment
  • Knowledge and experience with GxP practices, ICH, FDA, and USP guidelines is an asset
  • A life long learner mind set
  • A critical thinker

 How to Apply:

  • Please send your CV and cover letter to careers@eupraxiapharma.com .
  • While only short listed candidates will be notified, we thank each applicant for their submission.

Process Development Associate

Job Description:

To support our R&D and product development activities, we have an immediate opening for a Process Development Associate with our Research and Development group in the Vancouver, Canada office.

The successful candidate will be responsible for developing scalable processes to support process transfer to a contract manufacturing vendor. The candidate will be expected to work both independently and supervised to perform and document experimental results. In addition, the Process Development Associate will contribute to the drafting of corporate presentations, regulatory filings and batch production documentation.

It is also expected that the Product Development Associate will need to travel to contract manufacturers worldwide when required

Key Responsibilities

  • Perform process scale up and optimization experiments in the Vancouver Lab
  • Perform physical characterization of samples including SEM, optical microscopy, DSC, TGA, NMR, and XRD
  • Present findings at R&D and CMC meetings in a clear, concise manner
  • Work with contract manufacturers to streamline process transfer
  • Assist with department operations as requested (e.g. filing reports, data management)
  • Comply with required QMS procedures including maintenance of a signed laboratory notebook

 Requirements

  • BSc degree in chemistry, biochemistry, or chemical engineering: MSc is an asset. Candidates with proven experience are also encouraged to apply
  • Experience with crystallization, suspensions, coating techniques, and films are an asset
  • Knowledge of materials characterization techniques including but not limited to: NMR, FTIR, TGA/DSC, fluorescence microscopy, XRD
  • Knowledge of biological systems would be an asset
  • Excellent verbal and written communication skills
  • Ability to multi-task and work well in a team, specially a fast pace environment
  • Knowledge and experience with GxP practices, ICH, FDA, and USP guidelines is an asset
  • A life long learner mind set
  • A critical thinker

 How to Apply:

While only short listed candidates will be notified, we thank each applicant for their submission.

QA Regulatory Associate

Job Description:

The Quality Assurance and Regulatory Associate is responsible for the upkeep and monitoring of the Eupraxia Quality System, to ensure compliance with GxP and applicable international regulatory standards. In a regulatory capacity, the Associate will also assist in the preparation and maintenance of regulatory submissions and communications. To this end, the Associate will need to keep abreast of evolving changes in the regulatory environment, compliance policies and procedures.

Key Responsibilities

Regulatory

  • Compiles regulatory submissions and ensures filings to regulatory agencies
  • Liaises with departments within Eupraxia to obtain data and documentation required for submissions
  • Tracks progress towards regulatory submissions within established timelines
  • Maintain regulatory correspondence documentation
  • Contribute to regulatory budget management
  • Follow emergence of new regulatory standards and guidelines that may impact Eupraxia products
  • Perform regulatory intelligence on competitor products

Quality Assurance

  • Coordinate external audits, internal audits and gap analysis
  • With guidance, create, maintain and evolve the Quality Management system; oversee and maintain hard copies and electronic databases as appropriate
  • Coordinate and minute meetings for the Quality Management Committee and Management Review Meeting(s)
  • Oversee Document Control: Creation, revision, review, approval and control of documents
  • Review of complaint files, Nonconformity Documentation forms, and corrective/preventative actions
  • Maintain training system

 Requirements

  • Recognized degree in relevant field (health sciences preferred)
  • 2+ years of relevant experience (or demonstrated abilities) in a pharmaceutical environment
  • Knowledge of current regulatory guidelines for US, Canada and Europe (strongly preferred)
  • Quality Systems knowledge (strongly preferred)
  • General level of computer proficiency – Microsoft Office, Adobe Acrobat and document management systems
  • Excellent interpersonal, self management and organizational skills
  • Good technical writing skills

 How to Apply:

  • Please send your CV and cover letter to careers@eupraxiapharma.com .
  • While only short listed candidates will be notified, we thank each applicant for their submission.