Principle Clinical Manufacturing Specialist

3 weeks ago


Devens, Massachusetts, United States Bristol-Myers Squibb Full time
Transforming Lives through Science

Bristol-Myers Squibb is a leader in the pharmaceutical industry, and we're seeking a talented individual to join our team as a Principle Clinical Manufacturing Specialist. In this role, you'll have the opportunity to work on cutting-edge projects that transform the lives of patients and advance the field of medicine.

About the Role

We're looking for a skilled professional with a strong background in manufacturing and quality systems. As a Principle Clinical Manufacturing Specialist, you'll be responsible for assisting in process development, executing engineering runs, and implementing new processes into production. You'll also be expected to become an end-to-end process SME throughout all phases of production from clinical through commercial.

Key Responsibilities
  • Draft procedures and Master Batch Records for new processes under development
  • Design process flows that are suitable for commercial implementation
  • Understand and apply the criticality of Data Integrity and Quality Compliance in document drafting
  • Own change controls supporting deployment and continuous improvement of new processes
  • Execute operations on the floor to support process development and shake down
  • Leverage Lean operational principles while drafting procedures
  • Assist in equipment and process Qualifications wherever necessary
  • Become Manufacturing SME for all clinical processes implemented at site
  • Document reviewer for new and revised process updates
  • Train staff on process changes, transferring knowledge and the why behind changes
  • Network with Global team on Process Development changes and execute changes locally
  • Manage document lifecycle for related clinical manufacturing documentation, from editing through approval as appropriate
  • Complete periodic reviews of clinical documentation
Requirements

To be successful in this role, you'll need:

  • Bachelor's degree required
  • 5+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, cGMP knowledge, and production operations
  • 5+ years in a Manufacturing/Operations in a cGMP environment is required
  • An equivalent combination of education, experience, and training may substitute
  • Cell Therapy manufacturing experience preferred
  • Prior experience in a quality/manufacturing compliance role preferred
  • Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing
  • Ability to augment (M-F) shift to support development work at critical points
  • Ability to work in a cleanroom environment
  • Comfortable working with human blood components
  • Ability to be in close proximity to strong magnets
  • Experience in GMP Document writing and Change Control ownership
  • Quality Systems Change Management experience (change controls, CAPA, document updates, etc.)

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you're passionate about transforming lives through science, we encourage you to apply for this exciting opportunity.



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