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 portfolio, and decades of experience and expertise in nucleic acid drug delivery and development. We have laboratories and a key office based in beautiful Vancouver, British Columbia.
We leverage our innovative delivery systems and related technologies to bring new medicines to patients who need them. We do this by selectively collaborating with leading pharma and biotech companies and fostering a culture of innovation that allows us to maintain our leadership position in the space.
If you find that inspiring, we want to work with you!
Role Summary:
Genevant has an opportunity for a highly motivated individual to join our Manufacturing group as a Senior Associate. The Sr. Associate will support the transfer of lipid nanoparticle (LNP) drug product manufacturing from Genevant to global contract manufacturing organizations (CMOs), enabling the supply of LNP therapeutic products for clinical development programs. Reporting to the Sr. Manager of Manufacturing and Supply Chain, this person will play a key role within an experienced and supportive team.
Responsibilities:

• Assist to monitor manufacturing activities, equipment status and lipid supply inventory at CMOs.
• Participate in project meetings and when necessary, perform site visits to assure manufacturing objectives.
• Become proficient in Genevant's manufacturing technology and assist to manufacture key non-clinical LNP batches at Genevant to supply our partnered programs.
• Develop a thorough understanding of the QC methods applied for LNP formulation release testing.
• Participate in transferring Genevant manufacturing technology and in-process test methods to contract manufacturing organizations.
• Provide assistance during the remote oversight of engineering and GMP LNP batches at CMOs.
• Review executed batch records for GMP compliance.
• Assist in writing documentation used to implement technology transfer including Master Production Records, SOPs, development reports, manufacturing instructions, material specifications.
• Work with the Quality Assurance Group to investigate and document manufacturing process deviations in a timely manner.
• Support the raw materials supply chain process required for clinical LNP manufacturing through inventory monitoring at Genevant and remote contract storage sites. Maintain good communications with vendors to ensure timely delivery of long lead time, custom manufactured materials.
• Participate in the implementation of process improvements and equipment upgrades at CMO sites.
• Prepare and deliver presentations to communicate project progress and technical issues.
• Share production data with the Genevant Regulatory team to support preparation of IND and CTA dossiers.

Qualifications:

• BSc or MSc in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences or a closely related discipline
• A proven record of achievement, preferably with minimum 5 years experience in pharmaceutical manufacturing
• Prior Experience with technology transfer
• Basic understanding of GMP procedures for clinical manufacturing
• 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
• Ability to work independently to plan and complete job requirements within project deadlines
• Availability to work in multiple time-zones, depending on the location of the project sponsor or CMO
• Enthusiasm and aptitude for learning different production processes, analytical test methods and equipment operation
• Able to multi-task on several projects with a keen attention to detail
• Strong written and oral communications skills
• Adept at learning software if not already proficient (Microsoft Office, Adobe, Visio Professional)

Benefits & Compensation
We've worked to create an environment at Genevant that makes our people feel empowered, supported and appreciated so they can focus on doing incredible work that can change the future. To that end, we offer competitive salaries, performance bonus opportunity, as well as a generous benefits package including health, dental, vision, wellness, short- & long-term disability, accident death & dismemberment, and life insurance programs; company match towards retirement savings and ample time off through our flexible PTO and annual company shutdown!
The Canadian base salary range for this position is $77,000 – $116,000 excluding performance bonus and benefits. The base salary is determined by various factors including, but not limited to, education, qualifications, experience, and internal equity. The salary offered may be higher or lower than the posted range, depending on the candidate's qualifications and other factors.

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