Liquidia Technologies, Research Triangle Park, NC, is seeking a talented individual to join the pharmaceutical development team. This role will support research programs through development and scale-up of clinical and commercial formulations for pharmaceutical products including injectables, biologics and inhalation.
Job description
• Hands-on technical formulation leadership role in support of research/preformulation through clinical product development including process development and clinical trials material manufacturing in a range of dosage forms including nano and micro-sized particle drug delivery platforms.
• Develop and execute strategies related to product development, e.g. experimental design, data evaluation and formulation of relevant and scientifically based conclusions
• Develop a high level of expertise in process development of nano-and micron-sized particles
• Develop lyophilization, purification, sterilization, stability and packaging processes
• Investigate, troubleshoot and resolve technical issues associated with moving products from research through Phase I/II clinical studies
• Write technical reports and assist in the preparation of CMC sections for IND filings
• Partner and interact closely with Research, Clinical, Analytical, Manufacturing and Intellectual Property teams
• Hire and supervise technical staff; provide technical/procedure direction, training and mentoring
• Exchange and/or present technical information of specific projects
• Identify and manage appropriate supplier relationships as technical liaison
• Work across cross-functional teams and projects
Qualifications
• Formulation training with an advanced degree with minimum eight (8) years of formulation experience required
• Experience advancing multiple dosage forms and routes of administration strongly preferred
• Experience with therapeutic protein/vaccines drug development preferred
• Experience with multiple classes of drug products strongly preferred
• Experience working with colloidal dosage forms strongly preferred
• Strong experience with experimental design/evaluation
• Must be a creative, problem solving, detail oriented person with strong analytical skills
• Excellent oral and written communication skills
• Ability to manage and motivate scientific teams. Previous management experience strongly preferred
• Experience with GLP/GMP and IND filings required
• Ability to thrive in a multidisciplinary team environment is essential for success
Company Description
Liquidia Technologies is a privately-held clinical stage company focused on advancing vaccines and therapeutics that leverage the PRINT®technology for design and manufacture of engineered particles. The PRINT®technology offers unprecedented control of particle size, shape and chemistry in a highly consistent and scalable manufacturing process. In addition to its own products, Liquidia licenses its PRINT®particle technology and its GMP manufacturing capabilities to support proprietary programs advanced by collaborators.
