Manufacturing of Pharmaceutical Products
We are seeking a skilled professional to oversee the production of materials at various stages of the product lifecycle, including clinical, non-clinical, and pre-clinical stages.
The successful candidate will be responsible for handling batch preparation activities such as vial washing, load sterilization, and area preparation for production.
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Aseptic Processing and Compliance
This role requires performing activities in accordance with the required cleanliness classification of the production area, such as sterile, Grade A, or other.
Candidates will carry out sterile operations such as compounding, sterile filtration, and sterile filling.
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Collaboration on New Technologies
The ideal candidate will work with external vendors to help develop or improve systems related to single-use technologies, ensuring their effective integration into the manufacturing process.
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Preparation and Setup for Processing
Preparing components, tools, and equipment for processing into Grade A environments, ensuring the highest levels of sterility and readiness for production is crucial for this role.
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Multi-Product Suite Management
The successful candidate will manage transitions between different product campaigns within a multi-product suite, ensuring smooth changeover without contamination risks or operational issues.
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Environmental Monitoring
This role involves performing regular environmental monitoring to ensure the production environment maintains the required sterility and cleanliness standards.
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Regulatory Compliance
The candidate will ensure adherence to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and all relevant regulatory guidelines.
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Documentation and Reporting
The successful candidate will review and contribute to technical documentation, including manufacturing protocols, batch records, and reports.
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Cross-Functional Team Collaboration
This role requires actively participating in cross-functional teams, interacting with teams from R&D, Engineering, Quality Assurance, Supply Chain, Operations, and Validation to improve processes and address manufacturing challenges.
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EHS (Environmental, Health, and Safety) Compliance
The candidate will support and adhere to all Environmental, Health, and Safety (EHS) procedures and policies, ensuring a safe working environment for all personnel.
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