Manufacturing & Technology - Principal Scientist

FITS LLC; Manatí (PR); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation

Benefits package

Professional growth opportunities

Job summary

FITS LLC is seeking a Principal Scientist to lead technical transfer and support sterile parenteral manufacturing in the US islands. The candidate will collaborate across MS&T, process sciences, and technical services to ensure compliant, high-quality product transfers.

The role requires a 5+ year background in pharma/biotech, bilingual Spanish/English, and strong knowledge of cGMP and FDA requirements. This is a full-time, on-site opportunity emphasizing safety and precision.

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline and 5+ years in pharma/biotech.
• Shift: Administrative and according to business needs.
• Billingual (Spanish & English)
• Experience supporting MS&T, Process Sciences, Technical Services, or Technical Transfer.
• Strong knowledge of sterile manufacturing processes.
• Experience with liquid and/or lyophilized parenteral manufacturing.
• Knowledge of process validation and technology transfer activities.
• Experience writing and reviewing technical documentation.
• Understanding of cGMP regulations and FDA requirements.

Responsibilities

• Support sterile commercial manufacturing operations for liquid and lyophilized parenteral products.
• Provide technical support for technology transfer of Nulojix and Reblozyl.
• Assist Site Subject Matter Expert for formulation, filling, and lyophilization processes.
• Develop project plans and support execution of technical transfer activities.
• Design, develop, and execute experimental, characterization, and validation protocols.
• Support process validation and process performance activities.
• Coordinate cross-functional activities to ensure successful technology transfer execution.
• Participate as a core member of Technical Transfer and New Product Introduction (NPI) teams.
• Support manufacturing studies including Mixing, Filling, Lyophilization, Capping studies; PQ.
• Prepare, review, verify, and support technical documentation including transfer and validation docs.
• Participate in project meetings and provide technical recommendations.

Skills

Sterile manufacturing

Technology transfer

Parenteral products

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree in Chemical Engineering or related field

Job description

Principal Scientist

What Makes You a Fit:

The Technical Part:

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific discipline and five plus (5+) years of experience in the pharmaceutical or biotechnology industry.
• Shift: Administrative and according to business needs.
• Billingual (Spanish & English)
• Experience in:
• Experience supporting Manufacturing Science & Technology (MS&T), Process Sciences, Technical Services, or Technical Transfer.
• Strong knowledge of sterile manufacturing processes.
• Experience with liquid and/or lyophilized parenteral manufacturing.
• Knowledge of process validation and technology transfer activities.
• Experience writing and reviewing technical documentation.
• Understanding of cGMP regulations and FDA requirements.

The Personality Part:

• Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail that nothing gets past you. If this sounds like you, and if you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

As a Piece of Fits, you will: (The day-to-day on the job)

• Support sterile commercial manufacturing operations for liquid and lyophilized parenteral products.
• Provide technical support for the technology transfer of Nulojix and Reblozyl.
• Assist the Site Subject Matter Expert for formulation, filling, and lyophilization processes.
• Develop project plans and support execution of technical transfer activities.
• Design, develop, and execute experimental, characterization, and validation protocols.
• Support process validation and process performance activities.
• Coordinate cross-functional activities to ensure successful technology transfer execution.
• Participate as a core member of Technical Transfer and New Product Introduction (NPI) teams.
• Support manufacturing studies including: Mixing Studies, Filling Studies, Lyophilization Studies, Capping Studies, Washer & Tunnel Performance Qualification (PQ).
• Prepare, review, verify, and support technical documentation including: Technical Transfer Documents, Validation Plans, Mixing Study Reports, Excipient Holding Time Studies, Drug Product Holding Time Studies, Filling Machinability Studies, Lyophilization Studies, Capping Machinability Studies.
• Participate in project meetings and provide technical recommendations.

Being a Fits Piece Comes with Perks:

• Competitive compensation, benefits, and opportunities for professional growth.

Who We Are:

We are a Service Provider company that supports the Pharmaceutical, Medical Device, and Manufacturing industries in the US and the US islands, offering engineering, construction, maintenance, utilities, and specialized technical services. We prioritize the well-being of our employees and strive to deliver high-quality talent to our clients.

Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, or disability.