Lead Research Scientist, GMP Biopharma Process Development

Lonza; Tampa (FL); On-site; Confidential; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Performance-based compensation

Location-based benefits

Job summary

Lonza in Tampa, FL is seeking a Research Scientist III to design, execute, and interpret experiments for GMP process development and analytical method development. This fully site-based role requires mentoring junior scientists and presenting findings to stakeholders.

The candidate will collaborate with process development, manufacturing, quality control, and regulatory affairs to ensure product quality and compliance with cGMP. A PhD or equivalent industry experience is required.

Qualifications

• PhD with 5+ years in industry or MS with 8+ years or BS with 10+ years.
• Solid experience in biopharmaceutical development and regulatory awareness.
• Strong knowledge of cGMP and regulatory requirements.

Responsibilities

• Lead design, execution, and interpretation of experiments in GMP environment.
• Develop and implement analytical methods for drug substances/products.
• Troubleshoot complex issues and propose timely solutions.
• Author and review technical/regulatory documents and reports.
• Present findings to stakeholders and mentor junior scientists.
• Collaborate with cross-functional teams including process development and manufacturing.
• Stay updated on scientific advances and industry trends.

Skills

DOE (Design of Experiments)

Mammalian cell culture

Analytical method development

Statistical data analysis

Biopharmaceutical development

Leadership/mentoring

Education

PhD in Biochemistry or related field

MS in related field with 8+ years experience

B.S. with 10+ years experience

Tools

DOE software (e.g., Design-Expert)

Statistical software (JMP, SAS)

Analytical instrumentation

Job description

Lonza in Tampa, FL is seeking a Research Scientist III to design, execute, and interpret experiments for GMP process development and analytical method development. This fully site-based role requires mentoring junior scientists and presenting findings to stakeholders.

The candidate will collaborate with process development, manufacturing, quality control, and regulatory affairs to ensure product quality and compliance with cGMP. A PhD or equivalent industry experience is required.