Senior Bioprocess Scientist – Process Improvement

bdx; Cayey (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

Waters is seeking a Scientist III to lead process improvements, tech transfers, and GP initiatives in a regulated Bioprocess manufacturing setting. You will tackle complex problems with data-driven analysis, maintain GMP compliance, and coordinate across manufacturing sites.

The role requires 5+ years in the medical device or pharmaceutical industry, with experience in protein chemistry, conjugation, purification, or flow cytometry being a plus.

Qualifications

• Bachelor of Science in Biology, Microbiology, Biochemistry, Chemistry or related field.
• 5 years’ experience in medical device or pharmaceutical industry.
• Experience with protein chemistry, conjugation, purification, and/or flow cytometry is a plus.

Responsibilities

• Design and execute experiments at pilot/manufacturing scale to support data generation and analysis.
• Investigate product/process issues with minimal guidance.
• Analyze experimental data and plan follow-up experiments.
• Lead cross-functional projects with Regulatory, Quality, R&D, Engineering and Operations.
• Establish SOPs and logbooks for troubleshooting and data gathering.
• Review strategies for process and material qualifications.
• Communicate results to stakeholders to support decisions.
• Interface with departments and partners to support product development.

Skills

GMP knowledge

Quality Systems

Lean Six Sigma

Bilingual English/Spanish

Minitab or stats software

Lab techniques

Communication skills

Project leadership

Cross-functional collaboration

Education

Bachelor of Science in Biology/related field

Tools

MS Office

Minitab

Statistical software

Job description

Waters is seeking a Scientist III to lead process improvements, tech transfers, and GP initiatives in a regulated Bioprocess manufacturing setting. You will tackle complex problems with data-driven analysis, maintain GMP compliance, and coordinate across manufacturing sites.

The role requires 5+ years in the medical device or pharmaceutical industry, with experience in protein chemistry, conjugation, purification, or flow cytometry being a plus.