Process Development Engineer

Location: Worcester, MA
Department: Azzur Worcester, LLC

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Support the process development and process characterization studies for company's viral specific T-cell pipeline which includes both early and late stage therapies.
  • This individual will engage both internal and external partners to define process requirements, develop and characterize processes.
  • Drive the design, execution and analysis of process development studies to develop a thorough understanding of operational parameters and performance attributes, and the impact to critical quality attributes (CQAs).
  • Perform DOE (design of experiment) studies for identification of critical process parameters and parameter range finding.
  • Compile, organize, and analyze data across multiple experiments to enable process understanding and logical, data-driven decisions.
  • Author technical documents (SOPs, protocols, reports, risk assessments, specifications, CQAs), including drafting, reviewing, approval.
  • Support CMC regulatory submissions (IND, BLA, etc.) via authorship, review, approval of relevant CTD sections.
  • Support technology transfer to external manufacturing partners and provide support in process scale-up.
  • Provide laboratory support for manufacturing deviation investigations and evaluation of raw material and consumables changes



Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
  

 

Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.  All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 

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