Analytical Method Validation Consultant
Company: Invitrx Therapeutics Inc.
Position: Analytical Method Validation Consultant
Location: Lake Forest, CA
Posted: October 12, 2021
- Qualified candidates will possess a Master's degree/PhD in related fields along with 10 plus years related industry experience.
- Strong knowledge on Microbiological Quality Control Program (QCP) for the Manufacture of Human Stem Cells Products
- Familiarity with many aspects of validation is expected
- Flow Cytometer experience a plus
Implementing an In-House Sterility Testing Program for Stem Cell Products (SOP, workflow, training, final release) to include:
- Bac/T IOPQ review and test matrix for Invitrx stem cell products
- Updating current SOPs in place
- Creation of new SOPs required to operate and review Bac/T tested materials
- New product method suitability documents and testing
- Training of current and future staff on preparation and operation of Bac/T
- Required gap assessments
- Final release and disposition of Drug Product
Creating a Contamination Control Program to include:
- Review of current methods gapped to regulations and best practices
- Authoring contamination control strategy document
- Coordination of Disinfectant Efficacy and Viral Inactivation studies and review of all documents and summary reports including cleaning and process flow documents
- Authoring all Environmental Monitoring Performance Qualification (EMPQ) documents
- Coordination and execution management of EMPQ
- Authoring all Environmental Monitoring documents including surface monitoring, viable air (active and passive), non-viable particulate, and personnel monitoring
- Training of personnel on aseptic behaviors and best sampling methods
- Author and manage execution of a risk based environmental monitoring program
- Creation of a gowning certification program
- Review of equipment validation documents including incubators, refrigerators, and BSCs.
Laboratory and Testing System to include:
- Creating of an endotoxin and mycoplasma testing program
- Internal audit of current procedures and practices. (Quality Systems, Quality Operations, Laboratory, and Facilities)
- Providing high powered analytical validation development and characterization.
- Supporting analytical development and validation of methods related to the Flow Cytometry, Endotoxin, Mycoplasma, and Sterility test.
- Preparing and executing validation documents.
- Project execution for multiple systems validation.
- Develop Installation, Operational and simple Performance qualification documents.
$75 to $100 per hour based on experience
15-20 hours of work are expected per week and would need to be on site one full day (8 Hours) each week.
Most employees are vaccinated. Candidate should be vaccinated or be willing to wear a face mask and get tested before being on site.
Send resumes to firstname.lastname@example.org.