Parenterals Manufacturing Manager Biologics MSAT

gloor & lang ag seeks a Sterile Drug Product Manager for biologics in Neuchâtel. This 6-month on-site role focuses on manufacturing oversight, quality investigations, and CMO support for sterile parenteral products.

The company is looking for a Manager of Sterile Drug Product within its biologics division. This position is a fixed-term contract lasting six months. The successful candidate will oversee the manufacturing, compounding, and filling of sterile drug products, including vials, pre-filled syringes, and cartridges.

Responsibilities

• Lead investigations into manufacturing issues or customer complaints, performing root cause analysis, defining corrective and preventive actions (CAPA), and assessing product impact.
• Assist in analyzing process capability and conducting Continuous Process Verification for key quality attributes across various contract manufacturing organizations (CMOs).
• Evaluate the impact of proposed change requests on manufacturing processes.
• Review technical documentation and verify associated data to ensure accuracy.
• Identify opportunities for and execute projects that enhance process robustness.
• Contribute to annual product reviews and assess the performance of CMO partners.
• Support change management efforts, including CAPA identification and related activities at contractor sites.

Requirements

• Hold a scientific or engineering degree.
• Possess 3 to 5 years of experience in the commercial manufacturing of sterile drug products.
• Have hands-on experience with parenteral compounding and filling operations.
• Demonstrate fluency in English.
• Act as a subject matter expert in sterile manufacturing processes.
• Show strong knowledge of global regulatory requirements, such as FDA guidelines, regarding the design and control of these processes.
• Understand sterile manufacturing technology and processing techniques.
• Be experienced in investigating deviations, managing GMP changes, and handling complaint investigations.
• Be well-versed in relevant SOPs, cGMPs, and GLP guidelines.
• Be comfortable working and managing within a strict regulatory environment.
• Be able to lead cross-functional technical teams across different cultures.
• Have some capability in statistical analysis, including the use of statistical software platforms.
• Be involved in deviations, CAPAs, and risk assessments like FMEA.
• Understand the process, engineering, analytical, and regulatory aspects of sterile drug product manufacturing.

About the company

The client is a significant player in the biopharmaceutical industry, offering a wide range of globally established and recognized products. A substantial part of their value-added chain, from scaling up R&D processes to final product launch, is managed in Switzerland.

• The company is a major player in the biopharmaceutical industry.
• They offer a wide range of globally established and recognized products.