About Company:
Titan Pharmaceuticals, Inc. was incorporated as a Delaware corporation in 1992. Titan previously focused on developing therapeutics utilizing the proprietary long-term drug delivery platform, ProNeura®, for the treatment of select chronic diseases for which steady state delivery of a drug has the potential to provide an efficacy and/or safety benefit. ProNeura consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (“EVA”) and a drug substance. The resulting product is a solid matrix that is designed to be administered sub-dermally in a brief, outpatient procedure and is removed in a similar manner at the end of the treatment period.
Titan’s first product based on the ProNeura technology was Probuphine® (buprenorphine implant), which is approved in the United States, Canada and the European Union (“EU”) for the maintenance treatment of opioid use disorder in clinically stable patients taking 8 mg or less a day of oral buprenorphine. While Probuphine continues to be commercialized in the EU (as Sixmo™) by another company that had acquired the rights from Titan, Titan discontinued commercialization of the product in the United States during the fourth quarter of 2020 and subsequently sold the product in September 2023.
In December 2021, Titan announced its intention to work with a financial advisor to explore strategic alternatives to enhance stockholder value, potentially including an acquisition, merger, reverse merger, other business combination, sales of assets, licensing or other transaction.
Department:
Quality Assurance
Designation:
Executive/Senior Officer
Experience Required:
Executive: 5 to 7 years
Senior Officer: 3 to5 years
Key Responsibilities:
QC Analysis Monitoring: Perform online monitoring of Quality Control (QC) analysis and ensure the accuracy of raw data.
Analytical Test Report Review: Review analytical test reports for Raw Materials, Packing Materials, In-process Samples, Finished Products, Stability Studies, and Working Standards.
Validation Activities: Review analytical testing reports related to validation, including method validation, method verification, cleaning validation, hold time studies, and other validation activities
COA Final Review: Conduct final reviews of Certificates of Analysis (COA) for finished products, ensuring alignment with raw data.
Master Document Review: Review Master Specifications for Raw Materials, Packing Materials, In-process Samples, Finished Products, Stability Studies, MOAs, Test Protocols, and Test Reports.
Stability Monitoring: Oversee the withdrawal and analysis of stability samples as per the planner and monitor stability chamber activities.
Instrument Calibration: Monitor the calibration of QC instruments as per the schedule, ensuring compliance with SOPs and accuracy of calibration reports.
QMS Documentation: Review Quality Management System (QMS) documents, including Change Control, Deviation, Incident, and Investigation reports.
Issue Management: Initiate and manage Change Control, Deviation, Incident, and CAPA processes.
Error Management: Handle document ratifications and errata processes.
Incident Investigations: Conduct investigations of Out-of-Specification (OOS), Out-of-Trend (OOT), and incidents within the QC laboratory.
Audit Trail Review: Review metadata and audit trails in analytical software and reports to ensure compliance.
Data Integrity: Maintain the integrity of data in systems and documents, ensuring compliance with regulatory standards
Compliance: Ensure adherence to current Good Manufacturing Practices (cGMP) and organizational policies.
Work location:
Mahad