Sr. Principal Investigator
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Lonza Pharma & Biotech has an opening for a Senior Principal Investigator at their Bend, OR Location.
The Senior Principal Investigator is accountable for the formulation, process design, development, analytics and manufacturing for different technology platforms and client portfolios and leads the development of advanced ideas to enhance or improve the specific technology or portfolio broadly. The Principal Investigator applies advanced knowledge of chemistry, material science, and engineering to solve drug delivery, formulation, process, and manufacturing challenges to progress client programs through both early and late stage clinical development.
The Principal Investigator serves as the primary technical interface with the client and internal multi-disciplinary technical teams to define strategy for formulation, process, and product development and interface as the CMC lead for clients. They will oversee multiple cross functional product development teams for client programs to execute work plans against specific hypothesis and problem statements. They will review, interpret, and react to data to make tactical and strategic decisions in order to maintain or change product development plans for the portfolio and/or technology.
- Accountable for the technical success of client programs and advancing enabling technology platforms to advance our position in the industry
- Serve as the primary technical point of contact for the client programs (internally and externally) and present technical results and recommendations to the client
- Anticipate program risks, changes, and issues and manage program scope and project plan changes
- Recognizes trends in program pipeline and client problem statements and works with the site and commercial development to identify potential strategies/technologies to address opportunities and/or gaps
- Successfully prioritize and manage multiple programs across several phases of development (discovery through late stage clinical) and coordinate resources to deliver milestones across those programs
- Advanced understanding and execution of Chemistry, Manufacturing, and Controls (CMC) and able to support clients in developing regulatory submissions and/or supporting reports or regulatory interactions
- Lead, motivate, and mentor multi-disciplinary project team of internal SMEs (Subject Matter Experts), scientists, and engineers to meet technical milestones on appropriate timelines and provide technical feedback and recommendations at the project level
- Collaborate effectively across all departments at the site
- Work with the business development teams to secure new/critical business by representing Lonza Bend expertise in client presentations
- 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)
- Seasoned professional in pharmaceutical or related field
- Bachelors degree or higher in chemistry, engineering or pharmaceutical sciences or related technical degree
- Experience with tech transfer, regulatory, and GMP operations
- Experience working with oral drug products (Tablets, capsules, multiparticulates) and/or orally inhaled drug products
- Experience with oral bio-availability enhancement formulation approaches and unit operations
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
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.