Maryam Namiranian

• Perform routine testing and perform data analysis on drug product (DP) and drug substance (DS) material.
• Perform experiments/procedures in a quality and timely manner with limited supervision.
• Trained new laboratory associates.
• Support research and development effort to create new process and product.
• Maintained close communication with process development team to support upstream and downstream sample testing.
• Maintain a current, well-organized and detailed Electronic laboratory notebook (Benchling) .
• Recognizes issues and trends and communicates appropriately.
• Revise and write SOPs in Veeva Vault.
• Multi-tasked, ability to organize work and priorities in order to meet cycle times.
• Understanding of cGMPs, SOPs and USP procedures.
• Support technology and assay transfer to CDMO.
• Trained on variety of cell based assay.
• Reported data analysis through ELN/ MS Word/ Excel/ PowerPoint system.
• Support Quality Assurance on quality system and compliance activities as needed.
• Review of analytical CMC documentation.

Leading Microbiology Quality control team and all activities including:

• Endotoxin testing for in-process and final product.
• Microbial Enumeration and bioburden testing of incoming materials, in process and final product.
• perform qualifications and validations to assure products, processes and methods comply with specifications to support operational (Manufacturing and Product Development) strategies.
• Work with internal and external resources to maintain lab in an optimal state.
• Assemble reports on findings from environmental monitoring of cGMP facility, frequently update management on environmental trends and implement corrective action plans when necessary.
• Revise and review SOPs
• Monitor the GMP systems currently in place to ensure compliance with documented policies.
• Assist in preparing the plant for Clients and Federal inspections.
• Monitor and trend data.
• Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures.
• In-house qualification of media and reagent
• Perform microbial identification.

• Trained new laboratory associates.
• Maintained documentation on tests performed in lab.
• Oversaw items in inventory and reordered before supplies diminished.
• Understanding of cGMPs and SOPs.
• Performed testing and quality control using approved laboratory procedures and instrumentation.
• Preparation of Mini, large and 2d gels as well as loading and running them with different modified samples of DNA.
• Taking pictures of gel under UV.
• Prepare solutions for the production process.
• Leading the production team in clean room with machine vialing, hand vialing, labeling, capping, and torqueing.
• Responsible for following GDP, GMP, and GLP procedures and protocol.

• Swiftly and correctly calculate dosages, dispense medications, prepare prescription labels and fill prescriptions for approval by pharmacists.
• Use the pharmacy’s proprietary computer program to access prescription information including patient and prescriber data, drug selection, prescription interpretation and insurance billing.
• Inventory Management, Compounding, Automated Devices for Dispensing Drugs, Pharmacology and the Nervous System, Drug Classifications, HIPAA, Pharmacy Law, and Ethics.