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Research Associate II - Stability SME

Research Associate II - Stability SME

Vantive

6 - 12 years

8 - 14 Lacs

Bengaluru

Posted:1 day ago| Platform:

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Skills Required

ISO Technical writing Research Associate II Stability studies Quality systems Product design GMP New product development Data entry Recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

YOUR ROLE

The Drug Products and Sciences R&D Stability team supports research and development projects for new and existing products. The Research Associate II, Stability Subject Matter Expert, applies sound chemistry and stability planning knowledge to identify and evaluate stability indicating characteristics. The effective integration of chemistry and stability enables establishment of shelf life for new or existing products manufactured for rapidly growing markets and allows for the qualification of product changes on a global scale. The Stability Subject Matter Expert designs strategies and makes recommendations that may be non-routine to address technical, regulatory, and business requirements.

WHAT YOU WILL BE DOING

Represent R&D Stability on project teams as a member of the project teams goals and success.
Support development and implementation of stability strategies for new product development and sustaining project activities.
Support development of GMP stability studies used to establish expiration dating and support labeling for product development.
Contribute to the development of technical justifications for expiration dating for new or modified products and the defense of expiration dating recommendation to key business partners.
Provide valuable input to stability assessments and requirements for new products and/or current product changes.
Ensure the right methods and specifications are available for stability, compatibility, and release testing. Ensure that the methods are appropriate for the product design over shelf life.
Demonstrate the ability to identify risks, issues, and opportunities for improvement of existing methods, technologies, and approaches. Provide sound scientific rationale.
Interact with manufacturing facilities to acquire information related to test methods and specifications.
Author, review and verify technical data, protocols, and reports through use of Quality Documentation System.
Act as study director for stability projects under guidance of senior Stability team members.
Perform stability study administration activities on LIMS including study building and review, identification of product test data requiring modification, and data entry.
Support development of new and/or optimization of existing processes and procedures to enhance stability related practices.
Participate in investigations that correspond to atypical, out-of-specification, or out-of-trend test results. Review data and author technical evaluations that characterize the stability trending of suspect data under guidance of senior Stability team members.
Leverage critical thinking to drive the investigation to conclusions based on sound scientific principles.
Contribute to stability sections intended for submission to regulatory authorities under guidance of senior Stability team members. Use computerized systems to retrieve, evaluate, summarize data for reporting.

WHAT YOU WILL BRING

Under guidance of senior Stability team member, able to organize complex information and demonstrate attention to detail.
Logical and methodical when solving problems, developing solutions, and making sound recommendations with limited input from senior team members.
Experience working with sophisticated databases.
Possess relevant computer and technical skills including word processing, spreadsheets, table and graph generation, and use of databases and reporting tools.
Good technical writing skills.
Proficient in analytical chemistry including theoretical knowledge and practical experience.
Willingness to contribute efforts beyond own scope of responsibilities to ensure project milestones are met.
Basic functional understanding of FDA, ISO, and Quality systems.
Works well in a team environment across multiple time zones and demonstrates an inclusive attitude.

Education and/or Experience:

Bachelor s Degree with 8-12 years or Master s degree with 6-10 Years in a relevant scientific subject area.

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Research Associate II - Stability SME