Associate Manufacturing Specialist

We are seeking a highly motivated individual for the role of Associate Manufacturing Specialist to join our Manufacturing team. This position is based out of Santa Monica, CA as well as occasional travel to Tarzana, CA. The Manufacturing Specialist role will be responsible for ensuring successful manufacture and release of cell therapy products following all processes and procedures related to operations in full compliance with cGMP. This role will be driving and supporting the manufacturing operational readiness and successful tech transfer using knowledge of cGMP regulations.

Responsibilities:

• Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Assist in the development of Standard Operating Procedures (SOPs) for manufacturing processes.
• Assist in setting up manufacturing areas and equipment, including complex automated cell processing equipment.
• Follow all cleaning and gowning procedures for the facility.
• Maintain appropriate inventories of material and supplies within the cleanroom areas to support manufacturing activities.
• Ensure all materials and equipment are identified and available in time for manufacturing activities.
• Support Process Development and MSAT to align manufacturing plans with overall product development plans.
• Ensure that all production operations are controlled and executed within cGMP regulatory guidelines.
• Provide timely verbal and written updates to Manufacturing leadership.
• Support all new product/process introductions on site.
• Interact with vendors and outside resources.
• Complete assigned projects.
• Be the shift lead if required, providing instruction to the team.
• Troubleshoot and resolve operational problems during processing.
• Represent Manufacturing in cross-functional initiatives and meetings.
• Monitor and evaluate process trends and recommend and implement continuous improvement strategies as appropriate.
• Manage multiple projects independently.
• Plan and implement complex changes.
• Perform Environmental monitoring as required.
• Technical expert for entire area(s).
• Interact independently with regulatory agencies.
• Develop and provide training on complex manufacturing processes.
• Perform Manufacturing review and approval of critical documents.
• Develop process validation protocols.
• Maintain good housekeeping and clean and sanitize classified areas as required.
• Analyze complex problems and determine and implement solutions.
• Other duties and projects assigned to meet business needs.