Manager, Manufacturing Operations

Vertex Pharmaceuticals•Boston, MA

21h•Onsite

About The Position

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 DPF and DPF personnel while maintaining organizational balance across the group. The Manager will foster interdisciplinary communication and understanding within the group and with other departments. 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 [email protected]

Requirements

Bachelor's degree with preference in a scientific, technical or engineering discipline
4+ 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 in solid oral dosage forms and a sound understanding of the pharmaceutical development process
Experience with cleaning validation
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 Quality by Design (QbD) concepts, DoE, statistical process control (SPC) and complex data analysis

Responsibilities

Responsible for day-to day operation of the Drug Product 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 QDoCCS in support of GMP Operations.