Job Title: Senior Research Scientist - ADL
Purpose of Job
Responsible for delivering timely analytical results for Biotherapeutic projects, primarily focusing on characterization activities to support clone development, evaluation, and cross-functional teams within R&D.
Skill Required
-
Analytical Expertise: Strong understanding of characterization techniques and methods to support clone development and product evaluation.
-
Laboratory Management: Proficient in lab management, ensuring timely execution of experiments, maintaining proper documentation, and adhering to GLP and QMS.
-
Instrument Handling: Experience in handling and maintaining laboratory instruments with a focus on calibration and operational performance.
-
Regulatory Knowledge: Ability to prepare responses to regulatory queries and ensure adherence to regulatory standards.
-
Communication Skills: Effective in preparing reports, presentations, and communication across cross-functional teams.
-
Data Integrity: Knowledge of GxP data and adherence to Data Integrity standards.
Roles and Responsibilites
-
Project Management and Execution:
Manage and plan project work, supervise team members, and independently execute experiments when necessary. Interpret and conclude results, ensuring timely completion of daily tasks and documentation. -
Good Laboratory Practices (GLP) and Quality Management Systems (QMS):
Follow GLP practices and assist in maintaining lab procedures and QMS to ensure compliance with industry standards. -
Documentation and Reporting:
Prepare protocols, draft reports, presentations, and documents related to scientific projects. Ensure that resources are available and assist in planning, evaluating, and implementing lab systems and procedures. -
Instrument Management:
Perform instrument in-charge duties for allocated instruments, ensuring timely calibration and maintenance. -
Training Compliance:
Complete training for SOPs in the Training Management System (TMS) as per Intas requirements. -
Regulatory Compliance and Query Responses:
Prepare responses to queries from regulatory agencies in collaboration with relevant teams. -
Data Integrity and Compliance:
Adhere to Data Integrity requirements during GxP operations and review of GxP data (records, reports). Handle any potential data breaches through the SOP on 'Handling of Potential Data Integrity Observations.' -
Additional Responsibilities:
Perform any other duties as assigned by the supervisor, contributing to project success and departmental goals.
Qualification Required
PhD Biotechnology / MSc Biotechnology
Competencies
Relevant skills / Industry experience
8-10 Years of Experience
Biotech, Ahmedabad, GJ, IN, 382213