Research Associate II, stability

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Skills you'll use

What you'll do

• To provide support to the Stability Team in day to day technical and operational activities.
•  Develop stability study designs for new product development and sustaining product projects.
•  Without assistance, make sound technical recommendations regarding stability study designs for new product development and sustaining product projects that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
•  Employ appropriate techniques/methods to successfully and independently execute routine assignments related to stability study design and development within negotiated deadlines. Identify alternative methods and technologies for improving existing or new products/processes.
•  Maintain current/working knowledge of relevant QSRs and other regulatory requirements, such as the stability related ICH guidelines, for R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
•  Recommend appropriate study designs, techniques, and processes for a specified sequence of tasks where needed, including the use of LIMS systems for electronic stability protocols.
•  Contribute to technical feasibility analysis of complex products.
•  Demonstrate ability to apply technical theories and principles to projects within area of Expertise for nonroutine tasks. Analyse and determine best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications
•  Evaluate results relative to product requirements, definitions and/or program goals.
•  Providing technical rationale for expiration dating and label storage statement recommendations, preparing regulatory submissions, responding to regulatory communications.

Who can apply

•  Providing technical rationale for expiration dating and label storage statement recommendations, preparing regulatory submissions, responding to regulatory communications.
•  Ensuring compliance related deliverables are completed on schedule and per plan.
•  Independently plan and execute a series of stability study designs and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
•  Play a lead role in the evaluation, selection and adaptation of various techniques/strategies, which accomplish business objectives such as quality and cycle time.
•  Displays a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise.
•  In addition to having an in-depth knowledge and understanding of cGxP and related regulations and guidance, can be able to provide expert advice and/or is an active participant in the generation, review, adoption, and interpretation of such regulations.
•  Maintain focus on meeting both external and internal customer expectations.
•  Develop stability study designs for new product development and sustaining product projects.
•  Contribute to technical feasibility analysis of complex research and design concepts.
•  Evaluate results relative to product requirements, definitions and/or program goals.

About Baxter

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