Planning and Scheduling Supply Chain Sr. Manager
About the Job
The Planning & Scheduling Supply Chain Senior Manager role will own the schedules for the all cell manufacturing sites located in Cambridge and Boston. This role will also need to support master scheduling responsibilities for the device manufacturing facility in Providence until such time production is increased at all sites to refocus on Cambridge and Boston. This role will act as the hub for developing and managing a detailed (0-3 month) schedule that depicts CMC manufacturing work and process development. There is also a need to support QC and AD scheduling/forecasting needs. This role must also support the process for the clinical trials in collaboration with clinical operations, infusion nurses, QA, manufacturing, logistics and the clinical trial sites. This role is responsible to ensure the sites schedules are agreed upon, accurate and changes and issues are communicated and resolved on a daily basis. The role requires the ability to manage multiple activities simultaneously, balancing priorities, ability to work with ambiguity, and attention to details.
Lead weekly production scheduling meetings with cross functional team members
Key member of the daily coordination team meetings
Create, develop, align a scheduling process with key stakeholders to ensure production, materials, logistics are all in synch.
Establish a process that manages changes to the schedule, quick identification of material shortages in collaboration with planning and materials management
Develop schedule parameters to understand short term capacity constraints and mitigate against any impacts to plans with the supply planner
Support clinical trial needs by coordinating quick release product releases, prioritizing critical tasks for the QC, QA and mfg teams with close coordination with logistics. This role may support logistics with the vendor in the short term.
Responsible for drug product traceability and chain of custody between clinical and manufacturing sites in the clinical IRT system.
Collaboration with Quality to investigate exceptions in labeling, storage, and logistics activities
Serve as the business process owner for the production scheduling process during system / process implementations
Support with the writing and revision of supply chain related Standard operations procedures (SOPs)
Perform tasks in a manner consistent with the safety policies, quality systems, and GMP requirements
Ability to influence others and work independently and in a team environment
Establish scheduling Processes and best practices to support PD and Manufacturing needs
Bachelor’s Degree or equivalent with 10+ year of related work experience.
Work experience in a supply chain/ planning
Strong collaboration and communication skills
Ability to effectively plan, prioritize, execute, follow up and anticipate challenges
Experience managing complex schedules and priorities in dynamic environments
Ability to work, influence, and gain consensus across multiple functions (Manufacturing, Quality and Clinicals)
Strong analytical, problem solving and critical thinking skills
Expertise in use of MS Excel, as well as demonstrated proficiencies in Project, Visio, ERP systems and other applications
Good documentation practices
Excellent interpersonal, verbal, and written communication skills
Self-motivated, builds trust easily and operates with integrity and ethics
APICS CPIM Certification preferred
Experience working in a cGMP environment
Experience implementing or working in an ERP or scheduling tool
Experience with Cell therapy and gene therapies or cell culture process preferred