Manufacturing Downstream Lead
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Manufacturing / Production
Manufacturing & Industrial Operations, Pharmaceutical Manufacturing, Production QC/QA
Job Description & How to Apply Below
Matica Biotechnology is a viral vector and gene therapy Contract Development and Manufacturing Organization (CDMO) that leverages advanced technologies at its purpose-built cGMP facility in College Station, Texas.
With industry-leading expertise in process development, assay development, and cGMP manufacturing, Matica Bio serves as a trusted partner, seamlessly supporting its clients with streamlined operations throughout every stage of virus-based projects. Collaborating across five Matica sites worldwide, Matica Bio delivers excellence in the CDMO domain through innovations such as Mati Max™ proprietary cell lines, in-line process monitoring, and single-use technologies.
The true value of a CDMO is determined by the quality of its people. Matica Bio consists of a dedicated team of experts. We’re a CDMO powered by people. Come join our dedicated team and Make it Happen With Matica Bio!
Manufacturing Downstream Lead- Responsible for prioritizing manufacturing schedule requirements and executing the daily manufacturing schedule communicated by the Manufacturing Manager within a fast-paced manufacturing operation with primary activities including but not limited to Purification Techniques (TFF and Chromatography), Various Filtration Techniques, and Product Filling.
- Lead operations and act as the main point of contact within the cleanroom.
- Coordinate the transfer of all products related samples and assure the proper handover of samples to Quality Control department.
- Read and understand technical documentation and execute written instructions.
- Possess an advanced understanding and ability to put into practice cGMP principles.
- Possess advanced operational skills, troubleshooting skills and process advanced knowledge within an aseptic environment, biological safety cabinet or isolator to execute such processes as Filling, filtration, product transfer, product sampling, chromatography, and TFF (Tangential flow filtration).
- Possess the ability to train junior level manufacturing associates.
- Support in completion of root cause investigations and CAPA implementation.
- Get Involved in Equipment and instruments Qualification and Validation activities.
- Plan, organize and maintain material inventory for manufacturing processes.
- Clearly communicate problems and observations with manufacturing management and management from other departments.
Deliver to Plan:
Execute daily production operations within a cleanroom environment. The activities will include but are not limited to Cell Expansion in an aseptic environment, Bioreactor Operations, Depth Filtration, Purification through TFF (Tangential Flow Filtration), Chromatography and Various Filtration Techniques, and Product Filling via manual, semi-automated or automated filling.
Organize and Maintain:
Ensure clean rooms are cleaned, organized, maintained and audit ready at all times. Maintain department inventory and ensure all materials are kitted for upcoming cleanroom operations.
Training:
Maintain individual training plan and ensure your training profile remains up to date with training readiness at all times in addition to training junior level manufacturing associates.
Administrative Tasks:
Attending meetings, sending/receiving emails, participating in continuous improvement projects. When necessary, demonstrate strong technical writing abilities (Deviation initiations, work orders requests, SOPs, Logbooks, Working Instructions, Forms creation, etc.).
Perform other duties as assigned.
Any combination to include but not limited to M-F, Alternating Days, 8, 10, and 12 hours shifts. Ability to work nights, weekends and holidays.
As a Future Matican you bring:Education
AS/BS in Biotechnology, Biology, Chemistry, or equivalent
Pre…
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