Biologist I

Position Title: Biologist I

Work Location: Worcester, Massachusetts, 01604

Assignment Duration: 6 Months (Potential Extension)

Work Arrangement: Onsite

We are seeking a highly motivated Biologist I/II to join the Manufacturing Science and Technology (MSAT) department at our organization based in Worcester, MA.

As part of the PDS&T Biologics organization, MSAT leads the process technology transfer, optimization, validation, implementation, and continuous process improvement for late-stage and commercial manufacturing of therapeutic proteins.

We also provide technical support for manufacturing, GMP compliance, and regulatory filing.

Our mission is to support manufacturing and drive and implement improvement of processes and technologies for commercial products to deliver quality, compliance, financial and innovation goals for the benefit of our customers.

• Providing technical support to late clinical stage and commercial biologics manufacturing processes
• Supporting lab scale studies relevant to late clinical stage and commercial biologics manufacturing processes
• Support the writing and data review of official documentation relevant to late clinical stage and commercial biologics manufacturing processes
• Data monitoring and trending for continuous process verification
• Applying GMP and GLP principles to all aspects of work and documentation

• BS/MS degree in a scientific or engineering discipline with 0-2 years related industry experience
• Knowledge of applicable regulatory authority, compendia and ICH guidelines
• Ability to understand and independently apply GMPs and/or GLPs to everyday work with regard to documentation and instrument use
• Ability to utilize Microsoft Excel and Word to perform tasks
• Good written and oral communication skills
• Time management and project management skills
• Problem solving and troubleshooting abilities
• Ability to work in a collaborative work environment with a team
• Strong organization skills with high attention to detail
• Aseptic handling experience desirable
• Coding experience or advanced excel capabilities desirable