Manager, Manufacturing Operations page is loaded
Manager, Manufacturing Operations
Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-24529
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 as 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 ApplicationAssistance@vrtx.com
Help Us Achieve Our Mission
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency.
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on Facebook, Twitter/X, LinkedIn, YouTube and Instagram.
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.
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