Manager, Manufacturing Operations

Job Description

General Summary:

The Manager, Manufacturing Operations manages a team and gives oversight to the day-to-day operations of the Drug Product Facility. The responsibilities include defining and directing activities for the manufacturing personnel while maintaining organizational balance across the group. The Manager will foster interdisciplinary communication and understanding within the group and with other departments.

 

Key Duties and Responsibilities:

• Responsible for day-to day operation of the Manufacturing facility and maintaining a cGMP environment

• Direct the activities of the group through managing of staff, prioritization and assignment of tasks

• Responsible for aligning with site leadership to provide departmental and technical leadership

• Assist in departmental and interdisciplinary projects

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

• Author or review and approve batch documentation

• Perform event investigations, CAPA and change controls in support of production and the department

• Collaborate with other departments, both internal and external to coordinate maintenance down periods and equipment upgrades

• Identify and continuously work to improve practices, procedures and activities as related to the department and site

• Enable the timely achievement of departmental, site, and corporate goals

• Mentor, motivate, and evaluate the performance of group members

• Author and submit revisions to controlled documents in VeeQMS in support of GMP Operations.

 

Knowledge and Skills:

• Strong interpersonal, communication and organizational skills

• Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experience

• Proficiency with business tools such sample management systems, MES and similar tools used in pharmaceutical manufacturing

 

Education and Experience:

• Bachelor's degree with preference in a scientific, technical, or engineering discipline

• Typically requires 5 years experience or the equivalent combination of education and experience

• Supervisory experience with direct oversight and management of direct reports, assigning duties, job functions, selecting, training, and giving feedback.

• Experience in technology transfer, scale-up, and late phase clinical development

• Process Development experience and a sound understanding of the pharmaceutical development process

• Experience with cleaning validation

Flex Designation:

On-Site Designated

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