Manufacturing & Technology - Principal Scientist

For services as 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:

• One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out! 

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?