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Senior Manager, Manufacturing Operations

Semma Therapeutics

Semma Therapeutics

Operations
Boston, MA, USA
Posted on Tuesday, June 25, 2024

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 organizational balance across the group. The Senior Manager will foster interdisciplinary communication and 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 team’s 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 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