Senior Manager Site Readiness

Job Description

General Position Summary:

The Senior Manager for Site Scheduling is responsible for performing multiple activities in support of the T1 D program at Vertex Cell & Gene Therapy. The role applies proficiency in scheduling production related activities across all the cell manufacturing sites located in Cambridge and Boston. The Senior Manager for Site Scheduling will maintain a production schedule that depicts CMC manufacturing, process development studies, along with all facility related activities that are impactful to the manufacturing schedule. The Senior Manager will be responsible for ensuring seamless scheduling, efficient resource allocation, and optimal productivity across all sites. The CMC production schedule will be used to provide a forecast to cross functional teams to project key dates such as product harvest and patient infusion. The ideal candidate will bring a blend of analytical expertise, operational experience, and leadership skills. The ability to facilitate meetings and collaborate well with multiple teams, while focusing on key details needed to meet project program timelines is essential.

This position reports directly to the Associate Director of Site Scheduling

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Create, track, and maintain production schedule changes and progress in the planning application to provide visibility to all stakeholders to drive short- and long-term execution plans.
• Collaborate with CMC functional area leaders to ensure that the schedule is optimized
• Define, measure, and communicate key performance indicators and supportive metrics that track the effectiveness of production planning and manufacturing execution.
• Lead SCRUM calls as needed with cross functional team members to align and facilitate discussions on manufacturing updates, quality events, harvest, and dosing schedules as well as facility operations.
• Liaise with Materials Management and Manufacturing to help prioritize raw materials that need to be received and released. Proactively follow-up on outstanding items
• Check production readiness and material availability to enable execution of production schedule.
• Provide clinical target progress updates to primary stakeholders by utilizing the necessary software to track the internal path to release. Deliver weekly reports displaying dispositioning progress.
• Support with the implementation of any new Production Planning System along with other stakeholders.
• Serve as liaison between CMC, Clinical Operations and Global Medicines Development & Medical Affairs (GMDA) to align on T1D dosing strategy ensuring that operational and program goals are met.
• Ability to influence others and work independently and in a team environment.

Required Qualifications:

• 6+ years of experience in industry (GMP/pharmaceutical highly preferred).
• Expertise in predictive scheduling tools that allow for modeling, simulation, operator allocation and white space analysis. Experience using Real Time Modeling System (RTMS) or Primavera P6 preferred.
• Experience in understanding specific manufacturing process information as detailed in a master batch record (MBR).
• Demonstrated ability to work effectively in a collaborative, and fast-paced team environment, including influencing business leadership.
• Proven track record of driving change in a dynamic organization.
• Excellent interpersonal skills, verbal, and written communication skills.
• Highly skilled in data analysis, manipulation, and presentations, to include software skills with Microsoft Office - specifically Excel VBA, Power BI, Smartsheet and Asana.
• Knowledge of Oracle or related ERP systems.

#LI-onsite #LI-SV1

Flex Designation:

Flex Eligibility Status:

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