What are the responsibilities and job description for the Manufacturing associate position at Medix?
This is a night shift position, the hours are 10pm-6 : 30am.
About Us :
The company is dedicated to the manufacturing of biotechnology products for clinical and commercial use. We adhere strictly to FDA current Good Manufacturing Practices (cGMP) and other regulatory requirements to ensure the highest standards of quality and safety.
Job Summary :
The Manufacturing Associate is responsible for executing manufacturing processes in a controlled environment using aseptic techniques.
This role involves working with biotechnology products intended for human use, requiring adherence to stringent SOPs and regulatory guidelines.
Essential Duties & Responsibilities :
- Perform daily operations including weighing and dispensing of materials, operation of filtration systems, inoculation of mammalian or cytokine cells, fermentation, harvest, chromatography columns, and TFF operations.
- Conduct in-process testing (pH, conductivity, spectrophotometry, osmometry, cell counting, etc.).
- Prepare media and buffer solutions.
- Maintain accurate and timely completion of Batch Records and other cGMP documentation.
- Report any nonconformance or incidents to the Supervisor promptly.
- Assist in the technology transfer from Process Development to cGMP Manufacturing.
- Adhere to safety protocols and company policies and procedures.
Requirements :
- Education : Associate degree or higher in Biology, Chemistry, Biotechnology, or related field preferred.
- Experience : 2-4 years of experience in the biologics industry required.
- Strong understanding of cGMP guidelines and regulatory requirements.
- Ability to work effectively in a team environment and independently as needed.
- Excellent attention to detail and organizational skills.
Last updated : 2024-07-18
