Job Description

About the Company

This Positions will provide technical leadership and support within cross-functional teams with primary responsibility as subject matter expert in implementing late-stage manufacturing process control strategies of an autologous cell therapy product in preparation for process performance qualification (PPQ). This role requires on-site presence and engagement. The position will report to the Associate Director, MS&T.

About the Role

This role requires on-site presence and engagement. The position will report to the Associate Director, MS&T.

Responsibilities

• Support implementation of late-stage drug product manufacturing process control strategies and assess process performance by monitoring and analyzing process/product data
• Support authoring of SOPs for consumable categorization, qualification, and E&L risk assessment.
• Possess active knowledge of regulatory expectations and industry standards for late-stage gene therapy manufacturing; specific experience in cell therapy processes and process control strategies is preferred
• Provide input for selecting and justifying single use systems and solutions; specific experience in sterile processing or Extractables and Leachables risk assessment is preferred
• Support review, approval, and execution of ancillary PPQ protocols (e.g., buffer stability, in-process intermediate hold times) and associated summary reports
• Represent MS&T for protocol related investigations in cross-functional team of SMEs, propose robust and data driven corrective actions
• Maintain compliance with applicable regulatory requirements for cell and gene therapy products
• Attention to detail in all job functions; exercise discretion, judgment, and personal responsibility
• Perform in accordance with established company policies, procedures, and training assigned and relevant to the tasks performed
• Work efficiently toward specific measurable objectives with little direct supervision

Qualifications

• Bachelor’s or advanced degree in biology, biochemistry or closely related scientific discipline
• At least 7-10 years of MS&T experience in supporting GMP manufacturing of a cell/gene therapy product
• Knowledge of cGMPs, ICH, USP, FDA, PV Lifecycle and PPQ, current industry practices, and experience in interpreting and applying guidances
• Experience with risk assessment tools is desired
• Excellent critical thinking and technical writing skills
• Excellent interpersonal and communication skills to lead, facilitate, and follow

Required Skills

• Active knowledge of regulatory expectations and industry standards for late-stage gene therapy manufacturing
• Specific experience in cell therapy processes and process control strategies
• Experience in sterile processing or Extractables and Leachables risk assessment

Preferred Skills

• Experience with risk assessment tools
• Excellent critical thinking and technical writing skills

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