Description
Manufacturing Associate Downstream/Upstream
1st Shift
We are recruiting for multiple Manufacturing Associates-Downstream/Upstream for a biopharmaceutical, contract development and manufacturing organization (CDMO) specializing in the production of biologics, particularly for the early-stage development of new drugs.
Job Responsibilities:
- GMP Manufacturing: Executing and monitoring cell culture-based processes, ensuring compliance with GMP guidelines.
- Cell Culture Techniques: Performing routine tasks like media preparation, cell inoculation, and bioreactor operation.
- Quality Assurance: Collaborating with QC and QA teams to maintain product quality and regulatory compliance.
- Troubleshooting: Identifying and resolving process deviations.
- Documentation: Maintaining accurate and complete batch records.
- Technology Transfer: Contributing to process improvement initiatives.
- Training: Assisting in training junior team members and developing SOPs.
- Safety: Maintaining a clean and organized work environment and following safety protocols.
Job Requirements/Qualifications:
- Bachelor's degree in a relevant scientific field is preferred OR
- High School Diploma/Associate degree
- 2-5 years of experience in GMP manufacturing, with a focus on cell culture.
- Knowledge of bioreactor operations, aseptic techniques, and upstream or downstream processing.
- Familiarity with regulatory requirements (FDA, EMA).
- Problem-solving and analytical skills.
- Effective communication and teamwork.
- Attention to detail and documentation.
- Overall, the Manufacturing Associate position requires a highly skilled individual with a strong background in cell culture and GMP manufacturing.
- The role involves a combination of technical expertise, problem-solving skills, and a commitment to quality and compliance.
- Competitive Salary and Benefits Package
- M-F; 8am-5pm
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