Consultant - Project Manager - Biologics

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SUMMARY:

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This position provides managerial, scientific, and technical support to assigned projects. In addition to providing experience in biologics product development, technical transfer and approval, this position provides mid to senior level management support to teams through applying project management techniques to ensure plans are defined and executed in accordance with contract commitments. Interacts with a diverse group of colleagues both internally and externally in a professional and collaborative manner. Independent judgment is required to plan, prioritize, and organize diversified workload.

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ESSENTIAL DUTIES AND RESPONSIBILITIES:

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Serves as the intermediary between the technical and business day-to-day operations of product development to organize a project plan for complex projects that satisfies milestones and deadlines with required actions. May be required to identify the topics/subjects (e.g., Quality, Regulatory, R&D, Manufacturing and Marketing) needing further input from subject matter experts. Facilitates these conversations and prepares materials to ensure these communications are efficient and effective.

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Develops and manages project teams according to overall project timelines that define biologics product development programs from feasibility, through development, testing, technical transfer, and approval.

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Ensures project tracking and reporting updates are compiled for key stakeholders.

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Develops risk planning and mitigation strategies and ensures issue escalation plans are in place for each project.

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Serves as client liaison and/or team leader to provide support and direction to an assigned team.

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Assist with vendor selection, coordination and oversight, and contract management.

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May draft various project documents (e.g., user needs, risk management, protocols, reports, etc.).

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Proposes solutions and trade-off analyses to problems presented by project team and/or stakeholders, including the entire process from problem definition to pertinent concepts and solutions to facilitate project outcomes and goals.

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Demonstrates proposed solutions by developing appropriate communication materials (e.g., slides, documentation, flowcharts, layouts, diagrams, and charts).

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Collaborates with client and other functional area experts to deliver the most desired solutions for assigned projects to ensure delivery of quality outcomes.

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Enables potential regulatory application filing when appropriate through implementation plans.

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Adheres to stated policies and procedures relating to health and safety, and quality management.

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OTHER DUTIES AND RESPONSIBLITIES:

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Maintains and increases job knowledge by studying the state-of-the-art, ongoing research in the field, etc.; participate in educational opportunities; read professional publications; maintain personal networks; participate in professional organizations. 

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Note that this position description is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities that are required in the performance of this job. Duties, responsibilities, and activities may change at any time with or without notice.

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MINIMUM EDUCATION, SKILLS AND EXPERIENCE REQUIRED:

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BA or BS degree in health-related discipline. Minimum of five to ten years of professional project/program management experience with mandatory experience in biologics product development and experience with regulatory approval process preferred.

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Demonstrated experience as a self-starter and a fast learner; must work efficiently, both independently and within a team; must have excellent problem-solving skills and attention to details. Effective written and verbal communication skills are required and must be able to write clear reports, papers, proposals, etc., and efficiently discuss the same with other scientists, engineers, and customers.

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