Job Description

General Summary:

The Manufacturing Operations Senior Specialist role supports clinical manufacturing of cell and gene therapy operations. This role works with clinical manufacturing team through all phases up to and including commercialization, as well as supporting all aspects of manufacturing such as change controls, risk assessments, deviations and ownership of GMP documentation. 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 manufacturing material

• Facilitate improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented.

• Assist with root cause analysis using Veeva

• Develop corrective action plans and other relevant Veeva documents to resolve deviations.

• Author and submit revisions to controlled documents in Veeva in support of cGMP Operations.

• Assist with Manufacturing related change controls and manufacturing risk assessments.

• 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.

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 SOPs

• Proven technical proficiency of manufacturing equipment and processes and demonstrates reliable and constantly emerging technical skill in a number of methodological areas

• Demonstrates ability to explain usage of materials

• Demonstrates knowledge of cGMP as related to materials management and clinical manufacturing

• 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