Sr. Associate/Manager, Manufacturing

Genevant Sciences Corp.

Company Profile:

Genevant is a technology-focused nucleic acid delivery company with world-class platforms, the industry’s most robust and expansive lipid nanoparticle (LNP) patent estate, and decades of experience and expertise in nucleic acid drug delivery and development. We leverage our world-class delivery systems to bring new medicines to patients who need them, in collaboration with leading pharma companies. Our laboratories and offices are based in beautiful Vancouver, British Columbia.

Role Summary:

Genevant has an opportunity for a highly motivated individual to join our Manufacturing group as a Sr. Associate or Manager (level will depend on the experience and level of the successful candidate).  The Sr. Associate/Manager will play a key role in supplying mRNA lipid nanoparticle (LNP) drugs for multiple development programs. Reporting to the Director of Manufacturing and Supply Chain, this person will play a key role within an experienced and supportive team.

Responsibilities:

  • Manage the manufacturing activities, equipment status and lipid supply inventory at CMOs. Serve as Genevant’s representative in day-to-day communications and, when necessary, perform site visits to assure manufacturing objectives.
  • Hands-on leadership of in-house manufacturing process including preparing key non-clinical LNP batches for internal and partnered programs and coordinating release testing.
  • Participate in transferring the manufacturing technology and in-process tests to contract manufacturing organizations. Oversee the manufacture of engineering and GMP LNP batches at CMOs.
  • Write technical documents including Master Production Records, SOPs, development reports, manufacturing instructions, and investigation reports. Work with the Quality Assurance Group to investigate and document deviations in a timely manner, as appropriate.
  • Contribute to raw materials supply chain management through global inventory monitoring and vendor communications to ensure timely re-stocking of long lead time, custom manufactured items.
  • Participate in the implementation of process improvements and scaled-up equipment at CMOs.
  • Maintain the Genevant manufacturing suite. Monitor equipment performance and schedule maintenance as needed. Monitor and maintain inventory of production supplies.
  • Prepare and deliver presentations describing project progress and technical issues.
  • Assist with compiling and authoring CMC sections of regulatory submissions.

Qualifications:

  • BSc or MSc in Chemistry, Chemical Engineering or a related discipline, as relevant to the pharmaceutical / biotechnology industry
  • A proven record of achievement and at least 5 years pharmaceutical CMC experience, including technology transfer and management of contract vendors
  • Knowledge of nucleic acid-based therapeutics, lipid delivery systems and lyophilization preferred
  • Proven ability to work effectively in a team environment within a diverse organization and have a high level of independence for planning and executing project requirements
  • Ability to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Enthusiasm and aptitude for hands-on data analysis and laboratory bench work
  • Multi-task and effectively manage timelines
  • Strong written and oral communications skills
  • Proficient with Microsoft Office and with data analysis and graphing

To Apply:

Please use the following link: https://genevant.applytojob.com/apply/6KwBkgtSYj/Sr-Associate-Manager-Manufacturing