Associate Scientist II - GMP Process Lead

AbbVie; Worcester (MA); On-site; USD 95,000 - 130,000; Full time

Job summary

AbbVie is seeking a scientifically driven professional to serve as downstream technical lead for late-stage and commercial GMP manufacturing processes. You will author validation protocols and analyses, collect process data, perform monitoring and statistical analyses, and collaborate across cross-functional teams to drive continuous improvements.

Responsibilities include supporting GMP operations, root cause analysis, technical transfers and scale-up, and on-the-floor investigations.

Qualifications

• Bachelor’s degree (or equivalent) with 3+ years’ experience, or Master’s degree (no additional experience).
• Theoretical and practical knowledge to carry out job function.

Responsibilities

• Serve as the downstream technical lead for late-stage and commercial GMP manufacturing processes.
• Author validation protocols/reports and technical assessments to support process performance qualification and continuous process verification.
• Collect and organize process data to perform process monitoring and statistical data analysis.
• Communicate and present work.
• Collaborate with cross-functional teams to resolve technical challenges.
• Provide on-the-floor support of GMP manufacturing operations to support investigations and identify areas for process improvements.
• Perform root cause analyses, author impact assessments, and propose corrective and preventive actions in response to nonconformities/deviations.
• Manage relationships with contract manufacturing clients.
• Support technical transfers and scale-up of GMP manufacturing processes.
• Perform laboratory-scale studies to support investigations or process improvements as needed.

Education

Bachelor’s Degree or equivalent education

Master’s Degree or equivalent education

Job description

AbbVie is seeking a scientifically driven professional to serve as downstream technical lead for late-stage and commercial GMP manufacturing processes. You will author validation protocols and analyses, collect process data, perform monitoring and statistical analyses, and collaborate across cross-functional teams to drive continuous improvements.

Responsibilities include supporting GMP operations, root cause analysis, technical transfers and scale-up, and on-the-floor investigations.