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Senior Manager, Manufacturing Operations
3 months ago
Senior Manager, Manufacturing Operations page is loaded Senior Manager, Manufacturing Operations Apply locations Boston, MA time type Full time posted on Posted 3 Days Ago job requisition id REQ-22354
Job Description
At Vertex Biopharmaceutical Sciences and Manufacturing Operations (BSMO), our dynamic teams bring together the best biology, technologies, and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative cell and gene therapies (CGT) to patients as quickly as possible. At the newly designed Leiden Center 1 site in Boston Seaport and other greater Boston locations, Vertex envisions the growth of CGT pipelines research, development, and clinical manufacturing for emerging therapeutic modalities with the potential to treat and even cure Type I Diabetes.
The Senior Manager, Manufacturing Operations manages a team and gives oversight to the day-to-day operations of the Drug Substance and Drug Product (DSDP) manufacturing facility. This leader will define and direct activities for DSDP personnel while maintaining organizationalbalance across the group. The Senior Manager will foster interdisciplinary communicationand understanding within the group and with other departments.
The Senior Manager will work one of the following shifts :
Sunday - Wednesday, 1st shift (7:00 am - 5:30 pm)
Sunday - Wednesday, 2nd shift (12:30 pm - 11:00)
Wednesday - Saturday, 1st shift (7:00 am - 5:30 pm)
Wednesday - Saturday, 2nd shift (12:30 pm - 11:00)
Responsibilities include:
Builds and develops an efficient team of Supervisors, Senior Specialists and other direct reports capable of consistently producing clinical product according to cGMP standards. Includes hiring, orienting, training and coaching of personnel.
Leads receiving unit component of technology transfer and final process development for Manufacturing team. Includes transfer of method, materials, facility requirements, and documentation
Ensures cGMP compliance through direct oversight and education of team members
Manages scheduling of lots in coordination with cross-functional groups. Drives resource planning such as materials, personnel, and equipment to ensure seamless operation of manufacturing activities
Manage teams projects to achieve department and corporate goals, including managing timelines and leading group meetings
Create, revise and review controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing
Participate in investigations and CAPA when required
Receive and manage equipment alarms
Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking
Other duties and projects as assign as required to meet departmental requirements
Requirements:
10 total years of experience in biopharmaceutical process development and/or manufacturing (education may count for some experience). Prior experience working in process development and/or manufacturing of cell therapy products is strongly preferred.
Extensive mammalian cell culture experience
Prior GMP experience.
Knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)
Expertise in cell processing and culture technologies for clinical materials production required
Experience with 3-15 liter scale bioreactors for cell culture
Experience with 2D cell culture
Excellent computer skills including Word, Excel, Project, and Outlook
Flex Designation:
On-Site DesignatedFlex 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 Vertexs 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
Similar Jobs (4) Sr. Specialist, Manufacturing Operations locations Boston, MA time type Full time posted on Posted 30+ Days Ago Supervisor, Manufacturing Operations locations Boston, MA time type Full time posted on Posted 3 Days Ago Senior Manager, Manufacturing Technical Operations locations Boston, MA time type Full time posted on Posted 7 Days AgoVertex 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 Fortunes 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit 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 peoples 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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