Research Scientist I - E&L

Vantive Healthcare Technologies; Bengaluru; Presencial; INR 3.000.000 - 5.200.000; Jornada completa

Descripción de la vacante

Vantive Healthcare Technologies in Bengaluru seeks a Research Scientist to lead EL/Extractables Leachable programs for medical devices and drug products. You will design LCMS/GCMS/HRMS studies, interpret complex data, and act as study director across CROs and in-house labs, ensuring regulatory and safety compliance.

Collaboration with regulatory, quality, and preclinical teams is essential. The ideal candidate holds a Ph.D.

Formación

• Demonstrated experience in Extractables Leachable with hands-on MS (HRMS, LCMS, GCMS).
• Knowledge of regulatory expectations for trace analysis in drugs/devices.
• GMP/change control in a regulated environment.
• Experience working with global cross-functional teams on trace analysis projects.
• Independent problem solver with methodical approach to developing solutions.

Responsabilidades

• Develop and qualify state-of-the-art LCMS/GCMS/HRMS methods for extractable and leachable studies.
• Strategize and design EL studies for medical devices and drug products.
• Review complex analytical data and draw interpretation conclusions.
• Hands-on experience with structural elucidation and unknown compound identification.
• Apply risk-based scientific approaches within regulatory frameworks to support EL projects and change control.
• Collaborate with cross-functional teams to align trace analysis strategies with regulatory requirements.
• Write impact assessments, gap analyses and technical rationales for change controls.
• Maintain knowledge of Quality System Regulations relevant to chemical characterization during product development and safety.
• Interact with multiple functions to understand products, therapies, and regulatory requirements.

Conocimientos

Analytical chemistry

Mass spectrometry

Data interpretation

Regulatory compliance

Study design

Educación

Ph.D. in Pharmaceutical/Analytical/Organic chemistry

Herramientas

LCMS

GCMS

HRMS

Descripción del empleo

Job Summary

The successful candidate for this role will be part of materials, chemical characterization and EL team and will bring hands-on and technical leadership experience in trace analysis like EL and Nitrosamines for medical device and drug products. This Research Scientist role will entail utilization of expertise in analytical chemistry, mass spectrometry and other related techniques to perform gap assessments for medical device and drug products requirements and support change control activities across the Renal and Acute Care businesses within Vantive.

The successful candidate is expected to also have a strategic mindset and will work closely with regulatory, quality, preclinical and product design owning leaders to enable investigations and characterization of trace impurities in drugs devices to support on-market or new product programs. This role will also include planning and performing laboratory work in mass spectrometry including execution of laboratory studies at in-house laboratories and supervising in external CRO labs. The candidate will likely act as study director for multiple studies at any given time and is expected to have excellent skills in wet chemistry, spectroscopy, chromatography, mass spectrometry to enable efficient and effective execution of programs. The individual will author required reports (internal documentation and regulatory submissions) following pertinent internal and external guidelines that ensures safety and compliance of drugs or devices that Vantive makes. The candidate is expected to stay abreast of emerging sciences and technologies that influence chemical characterization for medical devices and drug products through active participation in relevant external forums / societies

Essential Duties and Responsibilities

• Develop and qualify state of the art methods using LCMS/ GCMS/ HRMS for extractable and leachable study of medical devices and drug products.
• Strategize and design EL study for medical devices and drug products.
• Ability to review complex analytical data pertaining to EL and other trace analysis. Draw data interpretation and conclusions
• Should have hands on experience with structural elucidation, unknown compound identification.
• Develop strategies to effectively apply a risk-based scientific approach within a regulatory framework to support trace analysis/ EL projects and change control activities.
• Collaborate with a multidisciplinary team of subject matter experts (e.g. EL, Materials, Biocompatibility and Toxicology) to develop trace analysis strategies that align to regulatory requirements for medical devices and drug products.
• Participate in EL change control impact assessments when applicable to trace analysis and work with cross functional team members (design owners, EL and materials SMEs, preclinical toxicologists, etc.) to determine a comprehensive testing strategy through writing impact assessments, gap assessments, technical rationales and documents related to such change controls.
• Maintain and apply current knowledge of relevant Quality System Regulations and other regulatory requirements related to chemical characterization during product development, design and safety.
• Interact across functions (Design Owning Organization, Project Management Organization, Regulatory Affairs, Preclinical, etc.) to understand products and therapies, as well as business, technical, and regulatory requirements to meet project needs.

Qualifications

• Demonstrated experience expertise in Extractables Leachable with hands-on experience in mass spectrometry (HRMS, LCMS and GCMS) and study design for medical devices and drug products.
• Knowledge of regulatory expectations related to trace analysis for drugs and devices.
• Performing change control in a GMP environment.
• Experience of working in global cross-functional teams for trace analysis projects
• Independent problem solver who can use a methodical approach to develop solutions and make recommendations.

Education and/or Experience

• Ph.D. / Post graduate degree(M Pharm, MSc, MS) in scientific discipline (Pharmaceutical, Analytical or Organic chemistry preferred) with a minimum of 10 years of relevant (EL, Mass spec) experience.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.