Imran Khan
Senior Expert / Principal Scientist
Hyderabad,TG
Summary
A highly accomplished and innovation-driven Senior Expert (Principal Scientist) with 16+ years of experience in the pharmaceutical industry, specializing in analytical development, validation, and regulatory submissions within a cGMP environment. Proven ability to lead cross-functional teams, drive process improvements, and ensure data integrity. Expertise in managing projects from conception to completion, with a strong focus on quality, efficiency, and adherence to timelines. Seeking to leverage extensive experience and technical skills to contribute to a leading organization focused on pharmaceutical innovation.
Overview
17
17
years of professional experience
1
1
Certification
3
3
Languages
Work History
Senior Expert (Principle Scientist)
Novartis Healthcare Pvt Ltd
06.2015 - Current
- Spearheaded project planning and prioritization, consistently achieving project objectives through effective project management methodologies.
- Served as an analytical expert for NCE and comparator molecules across various solid oral dosages, managing end-to-end project responsibilities and ensuring high-quality results.
- Led cross-functional product development projects, driving innovation and ensuring timely delivery of results.
- Proactively engaged stakeholders and drove project success independently, demonstrating strong leadership and initiative.
- Facilitated collaboration across teams and external partners through exceptional communication and stakeholder management skills, resulting in strong working relationships and successful project outcomes.
- Managed multiple projects simultaneously in a fast-paced environment, consistently delivering high-quality results within established timelines.
- Ensured compliance with all relevant policies related to business, regulatory, quality, environmental, and safety expectations.
- Reviewed CMC modules (S4, S7, P5, P8), including IMPD and IND/NDA submission modules, ensuring accuracy and completeness of regulatory documentation.
- Collaborated with cross-functional teams (QA, local and global stakeholders) to achieve project deliverables and goals, fostering a collaborative and results-oriented environment.
- Led the development, authoring, and review of CMC submission components and documentation, expediting the submission process and ensuring regulatory approval.
- Critically reviewed scientific information to assess technical merits and suitability of scientific rationale, ensuring clarity and adequate data support for conclusions.
- Communicated issues succinctly and logically, demonstrating strong oral and written communication skills and active listening abilities.
- Leveraged understanding of related fields (analytical testing and quality assurance) to provide comprehensive support for project activities.
- Proficiently applied GMP requirements throughout all project activities, ensuring compliance and data integrity.
- Contributed to innovation, product research and development, and quality and stability testing for various R&D sites of Novartis across geographies, driving advancements in pharmaceutical development.
- Actively involve in implemented ELN and Digival Digital's solutions, digitizing process records and periodic instrument qualifications, improving efficiency and data management.
- Demonstrated technical proficiency in reviewing and interpreting stability and release data for drug products, ensuring product quality and stability.
- Served as a Subject Matter Expert for GCDS (Chromeleon), GLIMS, dissolution, Assay, and degradation products development and Validation, providing technical guidance and support.
- Managed OOS investigations, deviations, change controls, and CAPAS as per GMP procedures, ensuring compliance and continuous improvement.
- Reviewed and approved analytical data, compiled data for submissions, and prepared stability protocols/reports, VP/VR, and TTP/TTR, ensuring data integrity and regulatory compliance.
- Prepared and reviewed quality documents (annual calibration reports, quality reviews, product quality reviews, stability study reports) and managed document routing and tracking in LIMS and Subway for approval.
- Acted as an investigation owner in TrackWise for OOS, OOT, analytical deviations, and laboratory investigations, compiling and tracking data for control charting and identifying areas for improvement.
- Mentored and trained associates and colleagues, guiding new joiners locally and globally within the organization, fostering professional development and knowledge transfer.
- Actively participated in the innovation and simplification department of Novartis, implementing new ideas for process simplification and supporting the evaluation of new technologies and tools for digitalization and automation.
Research Associates
Lupin Research Park
06.2010 - 05.2015
Research officer
Medley Pharma Pvt Ltd
02.2009 - 06.2010
Education
D-Pharmacy -
Nida College of Pharmacy, Rajiv Gandhi University of Health Sciences (RGUHS)
Bidar, Karnataka01.2025
Master of Science - Biotechnology
SRTM University of Nanded
Nanded, Maharashtra01.2008
Bachelor of Science - Chemistry
Sant Gadge Baba University of Amravati
Amravati, Maharashtra01.2005
Skills
Analytical Development & Validation
Project Management (Agile Principles)
Quality Assurance & Control (GMP)
Problem Solving & Critical Thinking
Regulatory Submissions (CMC Modules)
Tech Transfer Management
Data Integrity & Compliance (LIMS TrackWise ELN)
Risk Management & Mitigation
Cross-Functional Team Leadership
Process Optimization & Simplification
Stakeholder Management & Communication
Stability Studies Management
ELN Implementation & Management
Deviation & OOS/OOT/OOE Management
LIMS Management
Certification
Data Governance, Risk Management, and Compliance, 2010-06-01
Awards
- Recognized for outstanding contributions to project success and team collaboration.
- Acknowledged for consistently exceeding expectations and delivering high-quality results.
- Honored for leadership in promoting quality standards and ensuring compliance with GMP regulations.
- Recognized for exceptional performance and dedication to achieving organizational goals.
- Acknowledged for significant contributions to innovation and process improvement.
Accomplishments
- Recognized for outstanding contributions to project success and team collaboration.
- Acknowledged for consistently exceeding expectations and delivering high-quality results.
- Honored for leadership in promoting quality standards and ensuring compliance with GMP regulations.
- Recognized for exceptional performance and dedication to achieving organizational goals.
- Acknowledged for significant contributions to innovation and process improvement.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Languages
English
Bilingual or Proficient (C2)
Timeline
Senior Expert (Principle Scientist)
Novartis Healthcare Pvt Ltd
06.2015 - Current
Research Associates
Lupin Research Park
06.2010 - 05.2015
Research officer
Medley Pharma Pvt Ltd
02.2009 - 06.2010
Bachelor of Science - Chemistry
Sant Gadge Baba University of Amravati
D-Pharmacy -
Nida College of Pharmacy, Rajiv Gandhi University of Health Sciences (RGUHS)
Master of Science - Biotechnology
SRTM University of Nanded