Senior Scientist, MS&T & Tech Transfer (Parenteral)

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

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.