Manufacturing & Technology Principal Scientist

For services as Principal Scientist.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelors degree inChemical 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 youre 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 were 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 StudiesFilling StudiesLyophilization StudiesCapping StudiesWasher & Tunnel Performance Qualification (PQ).
• Prepare review verify and support technical documentation including:Technical Transfer DocumentsValidation PlansMixing Study ReportsExcipient Holding Time StudiesDrug Product Holding Time StudiesFilling Machinability StudiesLyophilization StudiesCapping 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 youll be amazed). However thats not all we have to offer. Talk with us to find out!

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys 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 industryclients with top-notch quality talent.Were FITS!

Are you the Next Piece