Associate Director, Formulations Development

Location
92121, San Diego
Posted
Sep 28, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Associate Director, Formulations Development

Position Summary:

Arcturus Therapeutics is looking for an Associate Director to join our leadership team.  In this hands-on role, you will guide our growing Formulation Development group and be responsible for designing, directing, planning, coordinating and troubleshooting all aspects of formulation and process development from early lead optimization to late stage development for lipid nanoparticle based formulations of nucleic acids.

In this Role You Will:

  • Design and direct development of lipid nanoparticle formulations of nucleic acids (liquid, frozen and lyophilized);
  • Direct all aspects of formulation and process development from discovery to late stage development. Ensure successful scale up of formulation production and purification unit operations from bench scale to larger scale manufacturing, and lead tech transfer activities;
  • Design, direct and manage studies aimed at screening of formulations including but not limited to physico-chemical screen, stability studies, bio-evaluation;
  • Actively contribute to development of analytical methods for physico-chemical characterization of drug product;
  • Serve as a scientific and technical leader in the organization in the area of lipid nanoparticle-based drug delivery systems of nucleic acids;
  • Serve as a leader and mentor to a group of formulations and process development scientists;
  • Represent formulation development function in various project team meetings and contribute to overall project goals and deliverables;
  • Author formulations/process development sections of regulatory filings (IND, NDA etc.)
  • Demonstrate scientific excellence through filing patents and publishing scientific articles in peer reviewed journals;
  • Represent company at scientific conferences and meetings;
  • Perform other duties as necessary.

About You:

  • Ph.D. in Chemistry or pharmaceutical sciences with 10+ years of direct industrial experience in design and development of lipid nanoparticle-based drug delivery systems for nucleic acids required;
  • Expertise and knowledge in scale-up of formulation production/purification unit operations and tech transfer activities for lipid nanoparticle formulations required;
  • Deep understanding of all aspects of formulation/process development and characterization including physico-chemical, stability and biological evaluation required;
  • Thorough knowledge and understanding of PK/PD and mechanistic aspects of uptake of lipid nanoparticle-based formulations required;
  • Excellent scientific publication and patent record in the field of lipid nanoparticle-based drug delivery systems required;
  • Exemplary leadership and mentoring skills and related management experience desired;
  • Must be an independent thinker with a passion for developing innovative formulation technologies;
  • Experience in writing pharmaceutical development sections of regulatory filings (IND, NDA etc.) desired;
  • Excellent oral and written communication skills required.

About Us:

Founded in 2013 and based in San Diego, Arcturus Therapeutics Ltd. is a publicly traded RNA medicines company. Arcturus’s commitment to the development of novel RNA therapeutics has led to partnerships with Janssen Pharmaceuticals, Inc., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, Ultragenyx Pharmaceutical, Inc., Takeda Pharmaceutical Company Limited, Synthetic Genomics Inc., and Cystic Fibrosis Foundation Therapeutics Inc..

Our corporate culture is diverse, open and creative. We value collaboration and teamwork. We are looking for team members to grow with us and with a strong dedication to the highest levels of scientific excellence.

Arcturus is committed to equal opportunity and complies with all applicable national, state and local laws governing nondiscrimination in employment.

For more information about our company, visit www.ArcturusRx.com.