Principal Scientist, Sterile Manufacturing & Tech Transfer

FITS, LLC; Manatí (PR); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation and benefits

Job summary

FITS, LLC in Manatí, Puerto Rico is seeking a qualified candidate to support sterile parenteral manufacturing and technology transfer initiatives. The role focuses on supporting MS&T, process sciences, and technical services with rigorous documentation and regulatory compliance.

The position involves collaborating on NPI projects, validating processes, and coordinating cross-functional activities to ensure successful tech transfer and manufacturing studies.

Qualifications

• Bachelor’s degree and 5+ years in pharma/biotech industry.
• 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 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: mixing, filling, lyophilization, capping, washer & tunnel PQ.
• Prepare, review, verify, and support technical documentation such as transfer docs, validation plans, study reports.

Skills

MS&T collaboration

Process sciences

Technical services/transfer

Sterile manufacturing

Parenteral manufacturing

Documentation & writing

Education

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Sciences, Chemistry, Biology, or related scientific discipline

Job description

FITS, LLC in Manatí, Puerto Rico is seeking a qualified candidate to support sterile parenteral manufacturing and technology transfer initiatives. The role focuses on supporting MS&T, process sciences, and technical services with rigorous documentation and regulatory compliance.

The position involves collaborating on NPI projects, validating processes, and coordinating cross-functional activities to ensure successful tech transfer and manufacturing studies.