Process Development Specialist
We are seeking a highly skilled and experienced Process Development Specialist to join our team. The successful candidate will be responsible for developing and implementing processes that ensure the highest quality and compliance standards.
* Collaborate with cross-functional teams to execute process development requirements for late stage clinical and commercial programs.
* Coordinate implementation tasks for new product processes, ensuring timely execution and minimal disruption to production.
* Develop and manage program introduction schedules to ensure efficient execution.
* Deliver GMP-compliant documents related to process development, including risk assessments and batch records.
* Support the development of process descriptions and other technical documents.
* Evaluate and implement opportunities for continuous improvement.
* Maintain high-quality, compliance, and safety standards.
* A minimum of 3 years' experience in pharmaceutical or biotech industry.
* Bachelor's degree in Engineering, Biotechnology, Chemistry, or related field.
* Technical knowledge of biologics drug substance operations and process development.
* Familiarity with automation systems and business tools.
* GMP-regulated manufacturing experience, preferably with single-use systems.