Principal Process Scientist

Flexible & Integrated Technical Services, LLC•Manatí, PR

About The Position

This role serves as a Principal Scientist, providing operational, scientific, and compliance support for sterile manufacturing environments. The position requires a strong background in manufacturing investigations, CAPAs, deviation management, triages, and procedural development. The ideal candidate will have expertise in supporting equipment troubleshooting and leading Technology Transfer projects.

Requirements

Bachelor’s degree in Pharma, Chemistry or Engineering
Five (5) years of exposure in the Pharmaceutical industry.
Extensive experience providing operational, scientific, and compliance support for sterile manufacturing environments.
Strong background in manufacturing investigations (QE's), CAPAs, deviation management, triages, and procedural development/revisions.
Proven expertise in supporting equipment troubleshooting and providing technical guidance to manufacturing operations.
Hands-on experience leading and supporting Technology Transfer projects, including project planning, team coordination, and new product introductions.

Nice To Haves

Being self-motivated, curious, creative, with an eye for detail.
Commitment to serving customers with high-quality research and products.
Embracing a diverse work culture.
Commitment to the environment.

Responsibilities

Performs as Subject Matter Expert in liquid, lyophilized and syringe parenteral processes, and formulation, maintaining a current knowledge base on best industry practices.
Supports Technical Transfer projects, including project plan development, team formation and charters for new product transfers.
Develop and execute experimental, characterization and validation protocols.
Partners with, Information Management, Engineering Maintenance, and Manufacturing to ensure equipment and automation are capable to deliver the manufacturing processes transferred.
Assures effective integration of plans and resources to achieve timeliness of process support, productivity, and technology transfer and validation activities associated to product portfolio.
Performs Design of Experiments and Process Risk Assessment (FMEA’) activities to establish appropriate process control strategies, perform equipment characterization exercises.
Partners with the site management team in the identification of best practices in industry related to technology transfers, pharmaceutical technology to create a competitive advantage.
Develops and maintains effective working relationships with other division groups in support of technology transfer, validation, productivity, and process support activities.
Performs as the communication liaison for the transfer, validation, optimization, and daily support activities for the assigned product portfolio.