Senior Manager, Internal LNP Manufacturing

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.

Our laboratories and offices are based in beautiful Vancouver, British Columbia (155 - 887 Great Northern Way, Vancouver, BC V5T 4T5) Position Summary Genevant works closely with many pharmaceutical companies employing our lipid nanoparticle (LNP) delivery platform to develop novel nucleic acid therapeutics.

To support the high demand for our LNP technology, we have established an in-house pharmaceutical manufacturing group to supply LNP formulated nucleic acids for numerous partner programs.

As the Sr. Manufacturing Manager, you will lead a team of manufacturing Scientists and Associates to manufacture, test and ship LNP drug products for multiple partner programs.

Responsibilities : Lead the in-house LNP manufacturing team for manufacturing nucleic acid-LNP drug product batches for pre-clinical evaluation.

Lead your team with hands-on participation in LNP manufacturing campaigns. Communicate with external partners and participate in project meetings to discuss scheduling and batch results.

Work closely with the process development team to implement new LNP manufacturing processes and process equipment. Develop procedures and prepare documents for scale up and tech transfer to contract research organizations (CROs) for GLP and GMP manufacturing.

Utilize your expert knowledge of LNP manufacturing procedures such as controlled mixing of fluids and tangential flow ultrafiltration (TFU) to ensure batch success.

Coordinate the release testing, packaging and shipping of the LNP products. Develop and maintain a master manufacturing schedule.

Prepare / approve technical documents including analytical test reports, master production records, SOPs, development reports, manufacturing instructions, and investigation reports.

Monitor inventories and ensure timely ordering of raw materials and consumables so manufacturing is never interrupted. Lead a cross-functional team with pharmaceutical sciences team members when required, e.

g. for larger batches or for making multiple batches per week. Maintain the pharmaceutical manufacturing suite in a clean and highly organized state.

Monitor equipment performance and schedule maintenance as needed. Conduct the training, supervision and performance evaluation of the In-house manufacturing staff.

Perform other job-related duties as assigned within your scope of practice. Requirements, Knowledge, skills, and abilities : BSc or MSc in Chemistry, Biochemistry, Chemical Engineering or a related discipline, with minimum 4 years pharmaceutical / biotechnology industry experience.

At least 2 years supervisory experience Ultrafiltration (TFF / TFU / UF) experience is essential. Knowledge of nucleic acid-based therapeutics, lipid delivery systems is preferred.

Experience with GLP / GMP manufacturing, scale up and tech transfer would be an asset. A proven record of achievement manufacturing pharmaceutical drug products for development.

A thorough understanding of laboratory hygiene practices required to sanitize process equipment and minimize microbial contamination while processing.

Proven ability to work effectively in a team environment within a diverse organization. A strong capability for independent planning and completion of production activities.

Ability to work in a fast-paced environment with great attention to detail. Ability to be flexible and adapt to changing priorities.

Enthusiasm and aptitude for hands-on data analysis and laboratory bench work. Highly effective multi-tasking skills. Strong written and oral communications skills.

Proficiency with the Microsoft Office suite. Compensation & Benefits 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 flexible paid time off. The Canadian base salary range for this position is $105,000 - $160,000, excluding performance bonus and benefits.

The base salary is determined by various factors, 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.

Department : Internal LNP Manufacturing Reports To : Sr. Director, Pharmaceutical Development Location : Vancouver, B.C.

Canada V5T4T5 Address : 155-887 Great Northern Way Version : 1 Term : Full Time Permanent Position Language of work : English Contact : [email protected] Powered by JazzHR