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To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor,
Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods.
Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.
Supporting the development of User Requirements Specifications of equipment
Support the commissioning and qualification of new and existing assets
Support the characterization of new or existing assets, identifying boundary limits, critical parameters, developing the testing strategy and statistical sampling plans
Provide support in investigations and the proposal and implementation of corrective actions related to investigations
Ensure activities follow cGMP procedures and are documented according to cGMP requirements including assigned training
Apply lean six sigma, operational excellence and continues improvement in assigned projects.
Develop business cases for new or modifications to existing systems, to determine feasibility based on business needs, including but not limited to demand, capacity, logistics, space, financial impact and head count
Writing of test protocols, perform technical evaluations and testing to support reports used to justify the use of selected materials and packaging components
Advanced scientific analysis and troubleshooting skills.
Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication
Written communication including technical writing skills, negotiation and conflict resolution Analytical problem solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).