Process Development Scientist

For Scientist Services in the Process Development: Inspection Projects area.

FITS is looking for a Process Development Scientist to support a leading biotechnology manufacturer. You’ll design and run the studies that keep commercial formulation and aseptic filling processes robust, then turn the data into clear decisions, reports, and improvements. If you enjoy connecting science to the manufacturing floor, this role is for you.

WHAT MAKES YOU A FIT: 

The Technical Part:

• One of the following:
  • a Doctorate,
  • a Master’s plus 2+ years of scientific experience, or
  • a Bachelor’s plus 4+ years of scientific experience
• Degree in a Science or Engineering field
• Shift: Administrative, depending on business needs.
• Project management skills are a plus
• Fully bilingual (Spanish and English), written and verbal

Preferred Qualifications:

• Commercial biopharma manufacturing experience in formulation and aseptic filling, with knowledge of protein science
• Process monitoring, data trending, and statistical analysis (e.g., JMP)
• Deviations, investigations, root cause analysis, and product impact assessments, including floor support in a 24/7 operation
• Strong technical writing for regulatory audits, plus communication, presentation, and cross-functional collaboration skills

• Conceive, design, execute, and interpret experimental strategies that support project goals, with general guidance from your supervisor
• Provide input on new processes to generate robust and reliable data
• Conduct studies in compliance with protocols, cGMP, and applicable guidelines and regulations
• Analyze and interpret data, and assess its impact on the project
• Develop and implement new protocols to address specific issues, introducing advanced scientific methods when appropriate
• Advise others on experimental design, data interpretation, and troubleshooting
• Independently author scientific reports, summary documents, and complex regulatory documents, as well as invention disclosures or patents when applicable
• Represent the department on project teams, and build productive collaborations inside and outside the department
• Stay current in your field, monitor literature and technology developments, and share relevant findings
• Participate in the external scientific community
• Take a lead role in department-wide efforts such as safety, recruiting, and committees as needed
• Supervise, mentor, and motivate others as opportunities arise
• Develop and follow timelines for project work while managing multiple priorities
• Apply advanced laboratory, analytical, and troubleshooting skills, using Word, Excel, and PowerPoint for documentation and presentations.

Being a FITS Piece Comes With Perks

• Work on high-impact projects with one of Puerto Rico’s top biotechnology manufacturers
• Opportunities to grow your career across FITS’ network of clients in pharma, biotech, and medical devices

Who We Are
FITS is a Puerto Rico-based engineering and technical firm. We connect skilled professionals with leading companies in regulated industries, including pharmaceutical, biotech, medical device, and manufacturing. We believe the right talent fits like the right piece, and we work to make every placement a match that lasts.