Principal Investigator, Associate Director CMC - Lonza Inc

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Lonza Pharma and Biotech has an opening for an experienced Inhalation Principal Investigator in their Bend, OR location.

The Inhalation Principal Investigator is accountable for the formulation and process design, development and manufacturing for the inhalation technology platform, including client programs focused on the inhalation or intranasal drug delivery route specifically around dry powder inhalers.

As the Inhalation Principal Investigator, you will apply your knowledge of chemistry, material science, and engineering to solve drug delivery, formulation, process, and manufacturing challenges to progress client programs focused on early, late stage clinical and commercial development. Oversees multiple cross functional product development teams for specific client programs to execute work plans against specific hypothesis and problem statements.  Reviews, interprets, and reacts to data to make tactical and strategic decisions in order to maintain or change product development plans specific for the client portfolio.

Key responsibilities:

• Accountable for technical success of client programs by working with the client and the internal Subject Matter Experts (SMEs) to define the program problem statements and technical program strategy
• Work with client to define and maintain appropriate Target Product Profile (TPP) to guide technical development strategy
• Primary client technical counterpart related to formulation, process, and analytical methods
• Present technical results and recommendations to the client.  Serve as the primary technical point of contact for the client programs (internally and externally).
• Define Intellectual Properties (IP) strategy for each program (by working with legal IP) that maximizes value for the client and Lonza by recognizing and pursuing new IP, utilizing existing IP, and / or establishing Freedom to Operate (FTO)
• Lead, motivate, and mentor multi-disciplinary project team of internal SMEs, scientists, and engineers to meet technical milestones on appropriate timelines and provide technical feedback and recommendations at the project level
• Collaborate effectively between different technical lines and support cross line collaboration
• Identify and propose new technical opportunities while working on client programs

Key requirements:

• Bachelor’s degree in chemistry, engineering, pharmaceutical sciences or a related field are required.  Masters or PhD preferred.
• Advanced knowledge of common inhalation analytical techniques such as particle sizing, impaction testing and delivered dose content uniformity required
• Substantial understanding and execution of Chemistry, Manufacturing, and Controls (CMC) to advance inhalation and intranasal programs through various stages of clinical development is required
• Experience with spray drying, other particle engineering techniques, and carrier-based platforms for inhalation drug delivery via dry powder inhalers preferred

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.