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