Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR-T Manufacturing

Role Summary

Specialist, Lead Manufacturing Associate, Cell Therapy Value Stream CAR-T Manufacturing. Lead manufacturing operations for novel cell therapy programs, supporting routine manufacturing operations with a focus on GMP compliance, safety, and quality. Collaborate with cross-functional teams to ensure on-time production and continuous improvement.

Responsibilities

• Execute operations described in Standard Operating Procedures (SOPs) and batch records
• Execute transactions and processes in electronic systems
• Demonstrate strong practical and theoretical knowledge in work
• Complete documentation required by controlled documents and batch records; ensure documentation is right first time
• Solve complex problems; apply new perspectives using existing solutions
• Foster relationships and collaborate through challenges/opportunities
• Perform tasks in alignment with safety policies, SOPs, quality systems, and GMP requirements
• Evaluate processing performance and communicate delays to leadership; proactively resolve issues
• Complete training assignments to ensure necessary technical skills
• Proficient in process systems and supporting business systems
• Assist in setting up manufacturing areas and equipment/fixtures as needed
• Collaborate with support groups on recommendations and solving technical problems
• Work in a cross-functional team to complete production tasks per shift schedule
• Collaborate with Shift Supervisors/Managers to pass down operational status
• Initiate deviations and support investigations / CAPA development; qualified as deviation investigator
• Complete change actions for change controls or investigations
• Initiate and facilitate triage calls; provide management support as needed
• Identify and propose innovative solutions
• Support writing manufacturing operating procedures that are technically sound and compliant with cGMP
• Train and qualify others on SOPs and Work Instructions
• Support production planning to execute daily unit operations schedule across multiple shifts
• Drive right first time (RFT) execution by providing training, guidance, and problem solving
• Aid in daily work coordination and distribution per production schedule
• Maintain schedule adherence and report variances to cross-functional groups
• Provide shift handover and ensure shift notes are complete and accurate
• Provide daily updates to functional groups as needed
• Maintain manufacturing environmental conditions per area classifications to meet Health Authority requirements
• Cross-train into multiple processes as operator/verifier
• Lead cross-functional projects and ensure timelines and deliverables are met
• Attend Leadership Development training and shadow managers for potential future responsibilities

Qualifications

• Basic Requirements: Bachelor‚Äôs degree and 4 years of cell therapy Biopharmaceutical operations experience; or Associate/Medical Technical degree and 6+ years of Manufacturing Operations; or High School diploma/GED and 8+ years of Manufacturing or Operations experience; 1 year of pharmaceutical industry training experience; 1 year of troubleshooting on the manufacturing floor; extensive knowledge of cGMP regulations and FDA guidance for cell therapy manufacturing
• Preferred Requirements: Experience in cell therapy manufacturing including cell washing, separation, cryopreservation; cell expansion using incubators and single-use bioreactors

Skills

• Leadership on the floor with schedule adherence; engineering principles and manufacturing systems
• Proficiency with word processing, spreadsheets, and web-based applications
• Strong interpersonal skills; professional relationships with area management and coworkers
• Senior Associate in Manufacturing as a pre-requisite

Education

• Bachelor's degree with 4 years of cell therapy Biopharmaceutical operations experience; or an equivalent combination of education and experience as detailed in Basic/Preferred Requirements