Senior Specialist, Drug Product Operations

Role Overview

The Manufacturing Senior Specialist Drug Product will contribute to the site's development and ensure successful GMP manufacturing, providing comprehensive manufacturing and technical leadership to the drug product organization in partnership with site MS&T.

Responsibilities

• Active participation in Process Hazard Analyses and Quality Risk Assessments as necessary.
• Active participation in factory acceptance testing (FAT) and site acceptance testing (SAT).
• Execute automation sprints as necessary in the drug product area.
• Support equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ, etc.
• Creation and revision of technical documents including manufacturing batch records, SOPs and technical memos.
• Provide Manufacturing and Technical expertise within the manufacturing team, including areas such as sterile supply, formulation, isolators, filling, lyophilization, capping and visual inspection (manual and automated).
• Execute the Engineering Batches, Process Performance Qualifications and commercial manufacturing.
• Support technical deliverables within Drug Product to support the successful product launch.
• Promote a Safety First, Quality Always mindset with Inclusion for all, fostering a Right First Time Culture.
• Provide technical support for RFT implementation and execution.
• Explain complex technical issues to external customers / agencies.

Qualifications

• Bachelor's degree in engineering, science or related discipline.
• 5+ years working in a cGMP biological, vaccine or pharma facility.
• Preferred candidate will have cGMP experience with biological, vaccine or pharma facility with prior aseptic manufacturing experience.
• Start-up experience in a large-scale commercial drug product facility highly desirable.
• Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
• Previous experience of manufacturing and technical support of placebo runs, developmental batches and PPQ runs.
• Experience with AVI/MVI and creation of library of defects.
• Experience in the following unit operations: formulation, sterile supply, filling, and lyophilization.
• Previous experience with CQV activities will be advantageous.
• Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma.
• Experience in a risk-based approach to manufacturing through use of tools such as FMEA.
• Ability to adapt to changing priorities as project demands change.
• Understanding of USP1790 and industry/regulatory requirements such as Annex 1.
• Demonstrated skills in planning, communication (oral and written) and in particular technical writing.