Senior Specialist, Drug Product Operations

Role Overview

The Manufacturing Senior Specialist will play a pivotal role in ensuring smooth operation of various aspects of manufacturing. In partnership with site MS&T, the Manufacturing Senior Specialist will provide comprehensive manufacturing and technical leadership to the drug product organization.

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.