Research Scientist III

Lonza Biologics, Inc.; Tampa (FL); On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Competitive compensation

Location-based benefits

Job summary

Lonza Biologics, Inc. in Tampa, FL seeks a Research Scientist III to lead the design, execution, and interpretation of GMP-focused experiments in process development for biologics.

You will develop analytical methods to support drug substance/product development and troubleshoot issues with timely solutions. You will mentor junior scientists, present findings to stakeholders, and collaborate with process development, manufacturing, quality control, and regulatory affairs while staying current

Qualifications

• PhD or equivalent with multi-year industry experience in biopharma.
• Solid oral dosage development experience; DPI knowledge preferred.
• Working knowledge of ICH/gmp practices and regulatory expectations.

Responsibilities

• Lead the design, execution, and interpretation of experiments for process development in GMP.
• Develop and implement analytical methods to support drug substance and product development.
• Troubleshoot complex issues and propose timely solutions.
• Author and review technical reports, protocols, and regulatory documents.
• Present research findings to internal and external stakeholders.
• Mentor and guide junior scientists, fostering professional development.
• Collaborate with cross-functional teams including process development, manufacturing, quality control, and regulatory affairs.
• Stay abreast of latest scientific advancements and industry trends in biopharmaceutical development.
• Ensure compliance with safety regulations and company policies.

Skills

DOE

Data analysis

cGMP

Cross-functional

Mentoring

Education

PhD in Biochemistry / Molecular Biology / Chemical Eng

MS with industry experience

BS with 10+ years experience

Tools

HPLC

Mass Spectrometry

CE

SPR

Job description

Research Scientist III

Tampa, FL

The actual location of this job is in Tampa, Florida, US. Relocation assistance is available for eligible candidates and their families, if needed.

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• A variety of benefits dependent on role and location.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do:

• Lead the design, execution, and interpretation of experiments for process development, optimization, and characterization within a GMP environment.
• Develop and implement innovative analytical methods to support drug substance and drug product development.
• Troubleshoot complex technical issues and propose effective solutions in a timely manner.
• Author and review technical reports, protocols, and regulatory documents.
• Present research findings to internal and external stakeholders.
• Mentor and guide junior scientists, fostering their professional development.
• Collaborate effectively with cross-functional teams, including process development, manufacturing, quality control, and regulatory affairs.
• Stay abreast of the latest scientific advancements and industry trends in biopharmaceutical development.
• Ensure compliance with all relevant safety regulations and company policies.

What we are looking for:

• Ph.D. in Biochemistry, Molecular Biology, Chemical Engineering, or a related scientific discipline with 5+ years of relevant industry experience, or M.S. with 8+ years of experience, or B.S. with 10+ years of experience.
• Solid oral dosage 5-10 years of solid oral dosage development experience, DPI (Drug Products Inhalation) experience preferred.
• Working knowledge of regulations to our industry preferably ICH/ICHQ8 practices.

• Extensive hands-on experience in mammalian cell culture, upstream/downstream process development, or analytical method development for biologics.
• Demonstrated expertise in experimental design (DOE) and statistical data analysis.
• Strong understanding of cGMP regulations and regulatory requirements for biopharmaceutical products.
• Excellent written and verbal communication skills, with the ability to present complex scientific data clearly and concisely.
• Proven ability to lead projects independently and effectively manage multiple priorities.
• Experience with advanced analytical techniques relevant to biopharmaceutical characterization (e.g., HPLC, Mass Spectrometry, CE, SPR).
• Strong problem-solving skills and a proactive approach to scientific inquiry.
• Proficiency in relevant software for data analysis and scientific reporting.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.