Specialist – Lead Manufacturing Associate

Specialist – Lead Manufacturing Associate

Requirements

• A minimum high school diploma and/or equivalent combination of education and experience is required.
• Associate or bachelor’s degree in related field is preferred.
• 4+ years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education.
• Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing.
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web-based applications.

Responsibilities

• Execute operations described in Standard Operating Procedures (SOPs) and batch records
• Execute transactions and process in all electronic systems
• Complete documentation required by governing controlled documents and batch records. Ensure that all documentation produced by their team is right first time.
• Solve complex problems; takes new perspectives using existing solutions
• Perform tasks in a manner consistent with the safety policies, SOPs, quality systems, and GMP requirements
• Evaluate team processing performance and communicate delays to leadership. Takes a proactive approach in resolving issues / bottlenecks.
• Complete training assignments to ensure the necessary technical skills and knowledge
• Provide assistance setting up manufacturing areas and equipment/fixtures, as needed
• Collaborate with support groups on recommendations and solving technical problems.
• Ensure the shift works effectively in a team based, cross-functional environment to complete all production tasks required by shift schedule
• Collaborate closely with Shift Supervisors/Managers to ensure seamless pass down and communication of operational status
• Initiates deviations and supports investigations / CAPA development
• Qualified as a deviation investigator and completes assigned investigations timely
• Completes change actions for change controls or investigations
• Initiates and facilitates triage calls, provides support to Management as needed
• Identify and propose innovative solutions
• Support writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements
• Trains and qualifies others on SOPs, Work Instructions to successfully complete manufacturing operations
• Support production planning to execute daily unit operations schedule that includes people, product, and material flow across multiple shifts as needed
• Drive right first time (RFT) execution of manufacturing unit operations by providing direct training, guidance, and problem solving
• Aid in daily work coordination and distribution as demanded through the production schedule
• Maintain schedule adherence and cycle time. Report variances and communicate impact to cross functional groups and managers
• Provide shift handover, as needed
• Ensure shift notes communication is complete and accurate, as needed
• Provide daily update summary to functional group for SQDCP, as needed
• Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements
• Cross-trained into multiple processes (as assigned) as operator / verifier
• Leads cross-functional projects and ensure timelines and deliverables are adhered to
• Attends Leadership Development training as development opportunity for career path as a future people leader
• Shadows manager(s) on leadership tasks in preparation for potential future responsibilities (including but not limited to, preparing production schedule, running team meetings, providing technical feedback to colleagues, giving recognition when deserved)

Preferred Qualifications

• Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired.
• Demonstrated aptitude for engineering principles and manufacturing systems.
• Experience in cell therapy manufacturing, including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.
• Cell expansion using incubators and single use bioreactors.