Job Description

General Summary:

The Manufacturing Process Engineering 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 tech transfer, change controls, risk assessments, deviations, and ownership of GMP documentation. Additionally, the Manufacturing Process Engineering Specialist performs a variety of support functions as determined by management and the needs of the department. The incumbent will have an extreme attention to detail, dedication to patients, and drive to learn and the ability to lead a team along with training their peers.

This role requires understanding and strict adherence to cGMP requirements for cell processing operations involving adherent and suspension cell cultures. The successful candidate will have prior experience in tech transfer to be able to generate batch records, SOPs, policies and work instructions to ensure successful and compliant drug substance manufacturing. In this role you will also collaborate with Process Development (PD), Analytical Development (AD), Quality Control (QC), Operational Quality, Material Management, Operations, and related stakeholders to drive efficient tech transfer of processes.

This is a First Shift (7AM - 4PM) role Monday to Friday schedule.

Key Duties and Responsibilities:

• Participate in tech transfer and final process development from process development to manufacturing group.
• Support the generation of master batch records, SOPs, work instructions, and other documents as needed for tech transfer projects for manufacturing in collaboration with development and quality groups.
• Facilitate improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented.
• Assist with root cause analysis utilizing 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.
• Write Master batch record and prepare MBR templates for routine drug product manufacturing activities.
• Other duties and projects as assigned to meet departmental requirements.

Knowledge and Skills:

• Knowledge in cell and gene therapy and/or tech transfer
• 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 for drug development and constantly emerging technical skill in a number of methodological areas
• Basic computer skills Word, Outlook, and equipment interfaces

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, development, and tech transfer of drug product manufacturing processes in a cGMP environment
• 6 months of experience with cell culture

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com