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
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) 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.
Are you the next piece?