Liquidia Technologies is a biopharmaceutical company transforming the development of new therapies by precisely engineering drug particles. Our proprietary PRINT technology is a simple, elegant solution that solves common problems with drug delivery and efficacy. PRINT technology is a scalable cGMP compliant process that creates particles and can apply to virtually any therapeutic area, molecule or route of administration. Liquidia is bringing more efficient, controlled development capabilities to the industry while enhancing the safety and quality of products for patients. Liquidia is advancing product candidates from its own pipeline. These initial product candidates, LIQ861 and LIQ865, apply the PRINT technology to better drug delivery in inhaled and pain therapeutic areas, respectively. The PRINT technology is also licensed with world-leading pharmaceutical companies that are developing future product candidates.
The Director of PRINT Process Engineering oversees process development for the manufacturing of novel particles for engineered drug delivery. In this new role, the Director will partner with the Executive Director, Particle Technology and collaborate across formulation and manufacturing functions to develop and scale PRINT processes that ensure the highest of quality and safety standards to supply clinical phase programs through commercial launch.
Specific Duties, Activities, and Responsibilities
Lead the development, scaling and optimization of the PRINT particle production process from Phase I to product launch in support of overall company goals and objectives
Work with R&D leadership to define goals for process development activities and manage budget/staff to ensure success
Utilize Quality by Design Principles in conjunction with DOEs to establish the process design space
Partner with formulation, manufacturing operations, analytical and QA groups in the development and execution of robust manufacturing process development activities
Drive the use of sound process engineering, basic Six Sigma tools and lean manufacturing to support development project teams
Lead and contribute in the authoring and review of relevant sections of regulatory documents including IND, NDA, annual reports, etc.
Ensure compliance to all company policies and procedures and to all applicable regulatory and legal requirements
Actively promote a culture of quality and safety
Supervise direct reports including interviewing, hiring, and training; planning, assigning and directing work; appraising performance' measuring, developing, rewarding and disciplining employees
Develop relationships with customers (internal and external), vendors and other members of management team
Education and Experience
BS/MS in a technical discipline (Engineering preferred)
7+ years' experience in process development or GMP manufacturing operations required, 3+ years in a leadership or supervisory capacity
Experience in Pharmaceutical industry required
Knowledge, Skills and Abilities
Demonstrated aptitude for 'hands-on' experimentation with an exemplary history as a "self-starter"
Strong leadership skills
Ability to collect information, identify key issues, analyze and summarize data and effectively communicate to business and technical audiences
Strong communications skills and ability to effectively interact with internal and external customers, top management and public groups
Experience with early stage product development and scale up in a cGMP environment is preferred
Demonstrated success in supervising, developing and coaching staff
Knowledge of Six Sigma/Process Excellence Tools including DoE process capability analysis, C/E Matrix, pFMEA, fish bone diagrams, etc. preferred. Lean Manufacturing experiences a plus.
Strong software skills including MS Office (Word and Excel) and ERP / MRP systems
Strong oral and written communication skills
Exceptional analytical, problem solving, organizational, and coordinating skills
All your information will be kept confidential according to EEO guidelines.
Liquidia Technologies, Inc.