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Company: Aerotek
Location: Summit
Posted on: January 15, 2021

Job Description:

Description:This position will support projects in External Manufacturing Cell Therapy Development Operations. He/she will be responsible for the project and operational management of activities from the initial formation of the team through agency filings (e.g. BLA, MAA, JNDA), commercialization and clinical/commercial manufacturing at Contract Manufacturing Organizations (CMOs). He/she will work with functional leaders from Global Manufacturing, Science and Technology (GMSAT), Quality Assurance/Quality Control (QA/QC), Regulatory-Chemistry Manufacturing and Controls (CMC), Supply Chain, Clinical Scheduling and Patient Operations to develop a project plan/timeline, carry out the execution and provide operational support. Identify activities on critical path and risks, development of contingency plans, cross-functional team meeting management and communication. We are looking for an individual with a breadth of professional experience to provide project management as well as operational support as needed. Ensure CMO operations that need BMS functional support are executed diligently. This role requires the ability to develop and maintain strong collaborative and cooperative working relationships with team members at CMO and across different functions and at different levels within the organization.Responsibilities:The roles and responsibilities include, but are not limited to, the following:* Provide operational and project management support to manage Contract manufacturing Sites. Manage multiple cross-functional projects, developing project overall plan and timelines, monitor and support execution and completion of various activities. * Closely work with Virtual Plant Team (VPT)support operational activities, issue resolution, and provide support to establish and execute strategic plans and day to day operations.* Work closely with QA/QC team to support internal multiple sites and Change Control and Deviation Management.* Support Patient Operations to resolve conflicts of clinical scheduling and further processing at internal site network. * Effectively collaborate with functional leads, develop critical path analyses to identify potential ways to accelerate timelines, reduce costs or mitigate risks, arrange and manage team meetings and follow up on action items.* Work with finance and VPT/Strategic Sourcing lead to provide support in tracking budget, Purchase Orders and invoices. * Serves as a member of sub-teams to assure that functional deliverables are completed on time, on budget, and in line with project overall plan.* Proactively identify project risks and work with the team and team leader to develop contingency plans.* Works with the functional leaders, develop KPI, team goals and objectives, as well as team presentations for Governance Committee meetings.* Responsible for the preparation of monthly status reports, including those for the Leadership Team* Promote a culture of collaboration, cooperation, execution excellence, effective communication and cross-functional problem-solving to function as a high-performing team.Key Competencies:* Broad knowledge of drug development, clinical and commercial manufacturing process in a GMP environment* Flexible to work with teams in different time zones across the globe* Strong analytical, problem-solving, and critical thinking skills* Demonstrated ability to earn the trust of team members and management* Must be able to interact and communicate effectively at all levels of the organization* Competent in Project Management tools and methodologies, e.g. MS Project, Visio* Excellent organizational and time management skills in a very fast pace and challenging and stimulating environment* Flexible and comfortable working with ambiguity as the program priorities change based on regulatory input, business, Research and Development (R&D) and clinical trial outcomes* Mindset for problem solving and focus on execution * Some global and local travel requiredEducation Requirements* Bachelors degree in Life Sciences discipline * Advanced degree in Life Sciences and/or MBA a plusAbout Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing-- Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.SDL2017

Keywords: Aerotek, New York , MANUFACTURING SUPPLY CHAIN PROJECT MANAGER, Executive , Summit, New York

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