Senior Biopharma Research Scientist – GMP Process Dev

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

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