Our client, a renowned leader in the field of biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. As a guiding force in the biotech industry, they set the bar for innovation and advancement. We are excited to announce a fantastic opportunity to join the team as a Manufacturing Associate! We are seeking a dynamic individual who is eager to contribute their expertise and drive their mission forward.
Located in Simi Valley, California
In this vital role you will be part of the Manufacturing Systems team which is responsible for supporting manufacturing activities through new product introduction, new technology and equipment introduction, continual improvement projects, supporting the multiproduct facility operation program, CAPA ownership, and optimization/implementation of single use technologies. The position is within the drug substance supply organization which is a dynamic environment and an important launch point for our client’s pipeline products.
- Support manufacturing by providing subject-matter expertise for drug substance upstream and downstream processes as process owner (PPO) or Single-use SME
- Lead projects using project management skills.
- Resolve quick issues and execute function tests to troubleshoot and optimize process
- Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management.
- Own Quality Records, such as CAPA, and CAPA-EV.
- Available to work various shifts (day, swing, graves, weekends, holidays, 5x8hrs, 4x10hrs) as instructed by the production schedule to execute function-testing and project tasks with minimal disruption to operations.
- Available to work on site
- Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves when performing all work while following GMP documents (SOPs) with strict adherence to safety and compliance.
- Apply technical process, scientific, operational, and compliance knowledge with analytical troubleshooting skills to support the implementation of new technologies into the plant.
- Demonstrate strategic problem-solving skills and champion continual improvement.
- As Process owner:
- Support operational readiness of new technologies, equipment, or processes by applying technical process, scientific, operational, and compliance knowledge with project management skills
- Develop/own drug substance manufacturing processes and procedures. Draft and revise GMP manufacturing documents (SOPs, Forms). Draft and develop user requirements for new technologies.
- As Single-use SME:
- Support New Product introduction and projects through SUS mapping
- Support manufacturing and quality through the SUS defect/leak triage process – perform troubleshooting on the floor, initiate investigation and bring leaks and defects to triage
- Initiate EN/SICAR records and follow process to conclusion, including working with vendors on investigation.
- Maintain up-to-date EN/SICAR/EE trackers and manage or lead small to medium projects
- Understand single-use material capabilities and user requirements for new technologies.
- Bachelor’s degree with 2-5 years of relevant experience, or Master’s degree
*Must be able to work a flexible schedule based on production needs*