Senior Research Scientist
3 weeks ago
Responsibilities:
* Provide technical and scientific expertise in the research and development of plasma derived or recombinant proteins or in support of the manufacture of plasma derived or recombinant proteins.
* Uses their expertise to assist in executing a compliant stability program to support licensed products and developmental projects, ensuring the on-going quality and safety of marketed material, in addition to implementing solutions to a variety of company related objectives. .
* Be responsible for providing stability support for products (marketed and/or development), generation of stability protocols and reports, reviewing and analyzing incoming data, and authoring Stability documents in support of Regulatory submissions.
* Participate in interdepartmental product project teams and present stability data to peer and management groups.
* Work in partnership with Manufacturing/Technical Operations/Supply Chain/Research and
* With supervision, develops action plans in support of departmental goals.
* Executes action plans independently or as part of a team.
* Capable of reporting project activities to immediate supervisor and within group meetings.
* Independently prepares procedures or technical reports, including data interpretation.
* With minimal supervision, prepares and effectively communicates technical results in cross-functional team settings.
* Independently applies sound scientific principles in development of solutions to complex technical problems within area of expertise.
* Applies professional principles, established techniques, and company's policies and procedures in completion of job tasks.
* Assists in the design of scientifically complex experiments.
* Executes and interprets results independently.
* Maintains work areas in accordance with company policies and industrial best practices.
* Provides support for research and developmental studies, clinical or commercial manufacturing as needed.
* Identifies, implements, and qualifies, as necessary, equipment to meet industrial best practices or achieve compliance with regulatory expectations.
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