Biotechnology Process Lead
2 days ago
The Biotechnology Process Lead will oversee the Upstream manufacturing operations, ensuring compliance with cGMP regulations and facilitating the development of new products or processes. This role requires strong leadership qualities, ability to coordinate resources, and excellent communication skills.
Key Responsibilities:
- Oversight of Upstream manufacturing operations, including organization, management, and improvement activities.
- Leadership and coordination of Upstream manufacturing staff to ensure timely delivery and right first time execution of manufacturing operations.
- Maintenance of highest level of cGMP compliance per FDA and customer expectations.
- Assistance in directing the Upstream manufacturing team to achieve productivity targets and output requirements.
- Collaboration with Manufacturing Director TBF, QA, Engineering, and Materials Management to ensure compliance and effectiveness.
Requirements:
- Master's degree in Science, Engineering, or related field, and four years of relevant experience, including four years of supervisory/management experience; OR Bachelor's degree in Science, Engineering, or related field, and six years of relevant experience, including four years of supervisory/management experience; OR Associate degree in Science, Engineering, or related field, and eight years of relevant experience, including four years of supervisory/management experience; OR High school/GED in a related field, and ten years of relevant experience, including four years of supervisory/management experience.
- Above experience must include four years' GMP experience.
- Experience with cultivation at a minimum of pilot scale cell culture vessels.
- Experience with Mammalian Cell, Insect Cell, Yeast, or Bacterial Cell Lines preferred.
- Experienced with pDNA, and Viral Propagation technologies preferred.
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