Companies you'll love to work for

Job Description

General Summary:

The Manufacturing Operations Senior Specialist role supports both clinical and commercial manufacturing of pharmaceutical drug product conforming to cGMP requirements. This role works with drug product development teams through all phases up to and including commercialization, as well as operating and maintaining the Drug Product Facility including the continuous manufacturing equipment. Additionally, the Manufacturing Operations Senior Specialist performs a variety of support functions as determined by management and the needs of the department.

Key Duties and Responsibilities:

• Manufacture and produce clinical and commercial drug product
• Facilitate improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented.
• Perform root cause investigations for events in Trackwise.
• Develop corrective action plans and other relevant Trackwise documents to resolve deviations.
• Author and submit revisions to controlled documents in QDoCCS in support of cGMP Operations.
• Prepare, review and/or audit technical documentation supporting GMP Operations.
• Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations.
• Write Master batch record and prepare MBR templates for routine drug product manufacturing activities.
• May also be required to support production activities on an occasional basis

Knowledge and Skills:

• Effective interpersonal, communication and written skills with the ability to work in a dynamic team environment, manage priorities, and maintain timelines for multiple projects.
• Demonstrates sound understanding of relevant drug development activities and SOP’s
• Proven technical proficiency of solid oral dose manufacturing equipment and processes and demonstrates reliable and constantly emerging technical skill in a number of methodological areas
• Demonstrates ability to explain why procedures or approaches are being used
• Demonstrates knowledge of cGMP’s as related to materials management and drug product manufacturing

Education and Experience:

• Bachelor's degree in a scientific, technical or engineering discipline
• 2 years of experience, or the equivalent combination of education and experience, in manufacturing and development of drug product manufacturing processes in a cGMP environment

Company Information