Manager of Analytical Development and Quality Systems

POSTED: August 17, 2022
BUSINESS: Toralgen
POSITION TYPE: Full-time
START DATE: Immediate Availability

Summary of Position

This position is responsible for developing testing procedures to evaluate and characterize nanoparticles for all therapeutic applications of strategic importance to the company.  This position will develop testing procedures and a lab quality system for all tests and experiments on nanoparticles.  This individual will also assist in particle formulation and the transition of process to contract manufactures as part of the scale-up of GMP production.

Key Responsibilities

Develop and execute Analytical testing procedures:

  • Lead all of Toralgen’s analytical testing for our proprietary poly-bile nanoparticle platform across a variety of therapeutic areas.
  • Serve as technical expert for the continued development of Toralgen’s poly-bile nanoparticle platform. Participate in business development discussions and due diligence activities.
  • Plan, design, and execute protocols; record, interpret and report results for complex studies. Integrate formulation development with PK and drug distribution study design.   

Support Polymer and Nanoparticle production:

  • Work closely with Director of Development to formulate and produce material required for studies and partnerships 

Quality System Development & Production Scale-up:

  • Establish and manage the quality system for Toralgen’s development lab. Lead development of testing procedures and creation of SOPs.   Ensure lab documentation that conforms with company quality systems and partner expectations. 
  • Provide technical guidance to contract manufacturer in process development and scale-up of GMP production. Guide the design, development and transfer of a new methods and formulations to manufacturing operations.
  • Provide recommendations to management on key technical capabilities needed for manufacturing testing

 

Basic Qualifications

  • Ph.D. Chemistry, Biochemistry, Drug Delivery, Engineering or other relevant fields with 5+ years of experience in nanoparticle drug delivery and development experience.
  • Significant experience in the development of analytical measurement
  • Understanding of and experience in development of lab quality systems
  • Analytical instrumentation including (pH, HPLC, UV-Vis, NMR, LC/MS), zeta-potential and particle sizing, HPLC and GC techniques, dissolution testing

Additional Skills/Preferences

  • Excellent organizational and project management skills. A proven history of driving projects to completion and achieving project timelines
  • Entrepreneurial and innovative approach to science/engineering; good judgment, risk taking and intuition
  • Experience with working in a networked technical organization with proven skills in collaboratively working with suppliers and alliance partners.
  • Ability to effectively influence, to gain commitment within team, cross-functionally, and across levels
  • Ability to work within a team and as a strong team player
  • Strong collaboration, communication and interpersonal skills to work effectively with a wide range of internal/external partners
  • Working knowledge of compliance issues and regulatory requirements

Additional Information

  • Position Location: West Lafayette, IN
  • Travel less than 10% both US and OUS
  • Reports to Chief Executive Officer

 

Interested applicants should send their resume to dnmoore@toralgen.com 

 

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