Process Development Expert
6 days ago
**Job Summary**
We are seeking a Process Development Expert to join our Manufacturing Technical Operations department. As a key member of our team, you will be responsible for developing and implementing process development activities, including specification, purchasing, designing, qualifying, and handing over effective manufacturing systems.
This role requires excellent technical skills, including proficiency in engineering standards required for cleanroom operations and familiarity with laboratory and manufacturing instruments/equipment. Additionally, strong leadership skills and ability to train others to perform to cGMP standards are essential for this position.
**Responsibilities:**
- Develop and implement process validation protocols, process specifications, BOMs, campaign summary reports, and other documentation.
- Lead operational technology standardization, standard batch templates, and instruction interfaces.
- Assist in transferring and scaling new processes and technologies to the manufacturing plant.
**Requirements:**
- Bachelor's degree in Science, Engineering, or related field, and two years of biotech manufacturing experience.
- Strong leadership skills and ability to train others to perform to cGMP standards.
- Familiarity with laboratory and manufacturing instruments/equipment.
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