Responsibilities
* Provide Technical Leadership within the Drug Product manufacturing team including areas such as Formulation, Filling, Lyophilisation, Capping and Automated Visual Inspection.
* Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
* Coordinate technical deliverables within Drug Product to support the successful product launch.
* Provide technical support to the operations team's during commercial manufacturing.
* Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
* Support Batch Disposition activities by providing SME technical support for comment resolution.
* Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Product
* Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.
* Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.
* In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DP organization.
* Participate in Regulatory, Client and Internal audits inspections as the technical representative.
* Delegate for Manufacturing Technical Lead.
Requirements
* Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
* Minimum 5 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience
* Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches
* Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma
* Experience in leading & resolving complex technical investigations
* 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
* Previous experience in an operations role within vaccine manufacturing preferred.
* Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirable
* Ability to explain complex technical issues to external customers / agencies
* Experience with lyophilized products advantageous
* Experience in start-up facility advantageous
* Demonstrated excellence in planning and organizational skills.
* Demonstrated skills in communication (oral and written) & in particular technical writing.
Desired Skills and Experience
Bachelor's degree in Engineering or a Science-related field.
Minimum of 5 years' experience in a biological, vaccine, or pharma facility, with strong preference for sterile manufacturing background.
Proven experience in equipment qualification (C&Q, IOQ), technical investigations, root cause analysis, and CAPA.
Skilled in applying Lean Six Sigma and risk-based tools (e.g., FMEA).
Excellent technical writing and communication skills are essential.