Location: Durham,NC, USA
Company Overview:
Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of potential therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
Position Overview:
This position is responsible for a central schedule / plan for the Beam Therapeutics site in North Carolina. The schedule is frequently reviewed for opportunities and adjustments based on input from Project Management and Operational Readiness, Supply Chain, Manufacturing, Quality, MSAT, and Engineering and Facilities. Clear and concise updates on the schedule changes are required and should be tailored to the audience. The role will live within the Project Management and Operational Excellence organization at Beam NC.
Responsibilities:
* Develop the Master Schedule through a coordinated effort with Manufacturing, MSAT, Quality, Operational Readiness, Engineering, Supply Chain, Finance, and IT. Collaborate with Site Leadership on scenario and resource (people, equipment, and facility) planning.
* Partner with Patient Supply and Clinical Operations for patient batch scheduling.
* Partner with site CMMS Administrator to integrate planned maintenance of manufacturing equipment, QC instruments, and utilities into overall Master Schedule.
* Partner with Engineering and Facilities to integrate CAPEX and project work affecting the facility or equipment into the Master Schedule, making the work duration and return to service time visible.
* Partner with Validation for ongoing CQV activities in Manufacturing and QC.
* Partner with the GMP cleaners on the cleaning schedule and assist with coordination of any required cleanings that involve return to service monitoring.
* Partner with QC on the Environmental Monitoring schedule.
* Partner with Supply Chain to ensure the plan in SAP includes the schedule, downtimes, and allocation of appropriate materials to process order. Complete releasing and maintaining of process orders in SAP. Ensure materials demands and timing are understood to meet the production schedule. Staging of BOM materials for process orders.
* Partner with Manufacturing, QC, QA, Supply Chain, and MSAT to produce a schedule that is executable, aligned with key deliverables, and aligned with key inputs from tech transfer. Develop resource requirements for manufacturing and develop resource models, as needed.
* Potential Opportunity: Scope and drive the selection of long-term scheduling software that is right sized for Beam NC. Partner with IT on the implementation of the software.
* Collaborate with Site Leadership to ensure buy-in for execution of the Manufacturing and CAPEX plans, based upon gained knowledge of the programs, projects and bottlenecks.
* Liaise with Project Engineers and 3 rd Party Project Managers to ensure Capital Project schedules are integrated into the site Master Schedule.
* Maintain site metrics for on time execution, schedule adherence, and others as determined by annual goals and objectives.
* Collaborate with Finance, as needed, to provide updates on schedule adherence and outputs from scenario planning.
* Daily facilitation of the Site Tier 2 meeting, as needed.
* Other duties and special initiatives related to Project Management, Operational Readiness, and Operational Excellence as assigned.
Qualifications:
* 8+ years' experience in the biotechnology, cell therapy or pharmaceutical industry is preferred.
* Bachelor's degree with a focus in business, engineering, or science.
* Ability to coordinate, facilitate and organize resources and information in a timely manner.
* Ability to develop strategic relationships, strong verbal, and written communication skills.
* Must possess good to excellent writing and computer skills with a knowledge base in Microsoft Word, Excel, PowerPoint, and Project. Smartsheet and Office Timeline Pro experience is a plus.
* Mathematical and reasoning ability.
* Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
* Ability to work under pressure to meet deadlines.
* Strong organizational skills with the ability to handle multiple activities simultaneously.
* Detail oriented and accuracy focused.
* Ability to persuasively champion strategic ideas, as supported by sound rationale and analysis, and drive change within the organization.
* Strong knowledge of concepts, practices and procedures related to the biotechnology, cell therapy or pharmaceutical industry preferred.
* Strong analytical, interpersonal, presentation and problem-solving skills.
* Ability to analyze, break-down, and interpret a wide variety of information and form a strategic opinion while addressing the operational implication and the opinions and recommendations of colleagues.