Process & Analytical Development SpecialistFull-Time position
Level: Specialist
Location: On-site in Philadelphia PA
Start date: Open
About the Position:We are seeking a passionate and skilled Process & Analytical Development Specialist to join our growing CMC team. In this role, you will play a pivotal role in advancing Verismo's cell therapy products by supporting process and analytical development activities. Reporting directly to the Senior Manager of Process Development, you will contribute hands-on expertise to scale up processes, analyze data, and support tech transfers to external manufacturing partners.
Essential Duties & Responsibilities: - Contribute to the setup and organization of Verismo Therapeutics' process and analytical development capabilities.
- Execute complex development studies (with multiple experiment sets) related to process development and scale-up, ensuring studies balance time and resources.
- Apply Quality by Design (QBD) principals to process development, characterization, establish process parameters, and contribute to CMC regulatory filings.
- Support next generation manufacturing processes and analytics for cell therapy and lentiviral vector
- Author technical and scientific documents including but not limited to SOPs, Master Batch Records, study protocols and reports.
- Ensure all documentation and reports are accurate, complete, and suitable for support of development, characterization, and regulatory approval of products.
Preferred Experience & Abilities: - Experience in a cGMP manufacturing and/or QC setting or process and/or analytical development laboratory
- Background in cell processing, scale up and tech transfer
- Working knowledge of analytical tools commonly utilized in cell therapy manufacturing
- Familiarity with quality by design (QbD) approaches and design of experiment (DoE) based studies
- Ability to function in a dynamic environment.
- Knowledge of GMP regulations as it pertains to best practices in cGMP manufacturing
- Experience with Good Documentation Practices (GDP)
Qualification Requirements:Bachelor's degree in a scientific field with at least 2 years of relevant experience.
