Job Description
A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Manager of Manufacturing of Science and Technology role. Our client, a leading pharmaceutical company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. Responsibilities include:
1) Lead the transfer of sterile biologics production processes and technologies from R&D into site operations
2) Be responsible for developing biologics process control strategy document, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D and ensuring that the manufacturing batch record meets established conditions as defined in the CMC documentation
3) Conduct process stewardship throughout the lifecycle management of commercial biologics
manufacturing processes
4) Design a Process Performance Qualification plan to demonstrate manufacturing process is
performing as expected to initiate commercial manufacturing
5) Oversee product technical lifecycle management about process control strategy process/yield improvement, process knowledge management, batch deviations, and
ensuring the accuracy of regulatory CMC registration detail
6) Support product pre-approval inspection, including direct interaction with regulatory agencies during site inspections
7) Prepare and review, as needed cGMP documents, such as batch records, technical protocols, and reports, change controls, deviation reports, validation protocols and summary reports
8) Work with the Operations and Validation Team to prepare an aseptic core package for submissions
9) Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes and container closure systems
10) Work with the Site Leadership Team to build subject matter expertise across functions in the areas of
compounding, sterilization, and Single Use assemblies for filtration and filling, device assembly and visual inspection
11) Work closely with the Operation and R&D Team to perform gap assessment for new product introduction and provide innovative solutions and develop a control strategy
Critical Requirements
1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceutical industry is strongly preferred
4) Preference will be given to candidates with recent experience in manufacturing management
If you are qualified and this seems like just the right opportunity to take your career to the next level, please apply – we want to hear from you!
Compensation and Other Details
Base Salary: Highly competitive package, commensurate with experience
- Published on 19 Nov 2023, 10:13 AM