Manufacturing & Technology - Principal Scientist

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

Qualifications

• 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.
• Experience in:
  • 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.

Personality & Fit

Being self‑motivated means you are curious, eager to explore possibilities independently while following instructions, creative, attentive to detail, and dedicated to delivering high‑quality research and products. You also embrace a diverse work culture and care about the environment.

Day‑to‑day Responsibilities

• 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: mixing, filling, lyophilization, capping, washer & tunnel performance qualification (PQ).
• Prepare, review, verify, and support technical documentation such as technical transfer documents, validation plans, mixing study reports, excipient holding time studies, drug product holding time studies, filling machinability studies, lyophilization studies, and capping machinability studies.
• Participate in project meetings and provide technical recommendations.

Benefits

• Competitive compensation and benefits package.