Manager, Scientist

Key Responsibilities: Responsible for process design/maintenance and continuous improvements. Lead execution and documentation of development and/or validation studies. Lead or supervise groups and/task force in the planning of engineering, investigations, definition and process validation runs. Document and interpret study results with recommendations. Provide technical leadership as an subject matter expert in multiple areas of responsibility. Develop and execution of training programs for appropriate audiences. Comply with cGMP and other internal and external quality and regulatory guidance. Comply with health and safety guidelines. Provide leadership, including project team leadership, within area of expertise. Context of the Job: The most significant aspects of the environment that affects the job and the most important problems to resolve to achieve the job's major purpose are listed below: Comply with platform procedures training Comply with cGMP and other internal and external quality and regulatory guidance. Comply with health and safety guidelines Job specific responsibilities: Provide expertise in process engineering Provide instruction, guidance, and direct support to laboratory technicians and operations on the correct execution of labwork Work collaboratively and cooperatively within MTECH and with Operations, QA, QV, and RA to accomplish business needs Write protocols, reports, procedures, and memos as needed to support seed optimization, sequencing, reassortment, development, etc. Perform troubleshooting at MTECH and operations with respect to the antigen production processes. Dimension/Scope of the position WHAT: A technical expert for process development, scale-up/down, and validation. Provide technical strategy input to departmental personnel and external contractors. Leads/conducts/supports execution of development and validation, including documentation Leads problem solving where analysis of situations of defined scope or data requires in-depth evaluation of identifiable factors. HOW: Receives limited guidance and instruction for proactively identifying issues and potential actions for resolution. Exercises judgments within defined practices and policies in defining process improvements, impact assessments, and troubleshooting. Demonstrates working knowledge of scientific principles used in process validation. Effectively cooperates across platforms and departments. Proactively anticipate and effectively communicate constraints, conflicts, solutions and actions for resolution Collaborate cross functionally with project management groups, Unit Leaders, and Program Leaders Basic Qualifications: Bachelors or Masters in basic sciences, math, engineering, or pharmacy with 3-5 years' experience OR PhD with 0-2 years' experience in biological processes in a cGMP environment. Familiar with validations, technological implementations, scale down/up, and technical supervision. Candidate should possess educational and professional experience, commensurate with the position. job id R2473351
Salary Range: NA
Minimum Qualification
Less than 5 years

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