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Biologics Manufacturing Specialist
3 weeks ago
We are seeking an experienced Manufacturing Technician to join our New Product Introduction team.
As a key member of the team, you will be responsible for all manufacturing activities necessary to support the tech transfer of new products, ensuring compliance with site and GMP procedures. Your duties will involve manufacturing, biologic drug product commercial support, and new product introduction/project management.
Key activities you will perform in this role include:
- Manufacturing of pharmaceutical products at different stages of lifecycle
- Batch preparation activities (vial washing, load sterilization, area preparation)
- Performing compounding, sterile filtration, and sterile filling activities
- Working with various vendors on the development/improvement of new and existing systems regarding single-use technologies
- Preparing components and equipment for processing into Grade A environments
- Aiding in running a multi-product suite, changing between different product campaigns without issue
- Performing environmental monitoring
- Complying with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)
- Reviewing and contributing to technical documents, including protocols, reports, and batch manufacturing documents
- Participating in cross-functional teams with other functions, including R&D, Engineering, Quality, Supply Chain, Operations, and Validation
- Adhering to and supporting all EHS standard procedures and policies
The ideal candidate will have a strong background in relevant disciplines, experience working in cleanroom environments, and knowledge of aseptic practices, GMP regulatory guidelines, quality systems, drug product manufacturing, and validation.
In addition, we offer a dynamic work environment that values diversity, equity, inclusion, and respect for our employees. Our company is committed to treating all employees with dignity and respect and promoting a healthy work-life balance.