Job Description
Job Summary
Job Title Research Scientist - I
Location Whitefield, Bangalore
Shift General
Your Role at Vantive:
The successful candidate for this role will be part of the Analytical Chemistry and Stability (ACS) team and will bring hands-on and technical leadership experience in Elemental analysis for medical devices and drug products. This Research Scientist role will entail utilization of expertise in analytical chemistry, Atomic Absorption (AA), Inductive Coupled Plasma techniques (ICP-OES, ICP-MS) and other appropriate techniques to perform gap assessments for medical device and drugs 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 of trace level Elemental Analysis in drugs & devices to support on-market or new product programs.
This role will also include planning and performing laboratory work in AA, ICP-MS and ICP-OES, including independent execution of laboratory studies at in-house or external labs for Method Development and Validations. The candidate will likely act as study director for multiple studies at any given time and is expected to be able to do wet chemistry, AA, ICP-MS and ICP-OES hands-on as required from time to time for efficient and effective execution of the program. 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 drugs through active participation in relevant external forums / societies.
Essential Duties and Responsibilities.
- Develop strategies to effectively apply a risk-based scientific approach within a regulatory framework to support trace level Elemental analysis projects and change control activities.
- Develop and Validate Methods for Elements and Elemental Impurities using the ICP-OES, ICP-MS and other relevant techniques.
- Define strategy for conversion of legacy AA methods to ICP and prove the equivalency between two techniques by following appropriate statistical methodologies.
- Collaborate with a multidisciplinary team of subject matter experts (e.g. ACS, E&L, Materials, Biocompatibility, and Toxicology) to develop trace level Elemental analysis strategies that align to regulatory requirements for medical devices and drug products.
- Participate in ACS change control impact assessments when applicable to trace Elemental impurities analysis and work with cross functional team members (design owners, E&L SMEs, materials, preclinical, 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 of 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.
- Should have knowledge, experience, and responsibilities on the matter that are essential for ensuring Manufacturing Plants can escalate and share any concerns regarding compliance to quality system for Management and Control of Elemental Impurities and Elemental Impurity Risk Assessments .
Qualifications.
-Demonstrated experience in applying Elemental Impurity analysis methods and tools as part of R&D
-Knowledge of regulatory expectations related to Elemental analysis for drugs and devices.
-Performing change control in a GMP environment.
-Experience in working in global cross-functional teams for trace Elemental Impurities analysis projects
- independent problem solver who can use a methodical approach to develop solutions and make recommendations.
Education and/or Experience.
Bachelor s degree in scientific discipline (Analytical or Organic chemistry preferred) with a minimum 14 years of experience, or MS with a minimum 7 years of experience or PhD with a minimum 3 years of relevant experience.
