Process & Analytical Development Specialist

Verismo Therapeutics•Philadelphia, PA

6d•Onsite

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.

Requirements

Bachelor’s degree in a scientific field with at least 2 years of relevant experience.

Nice To Haves

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)

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.