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Role reports to:
Manager - Analytical R&D位置:
Asia Pacific, India, Maharashtra, Greater Mumbai工作地點:
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Senior Scientist, R&D Analytical
Role reports to: Principal Scientist, R&D Analytical
Location : Mumbai
What you will do
The Senior Scientist position will be a part of the team that is responsible for analytical deliverables of new product development projects, support changes to existing products and specific research-based activities, product investigations, etc. assigned as a part of Global operations. The delivery of the projects is expected to meet applicable compliance and quality requirements and established performance metrics. You will play a crucial role in ensuring the safety and quality of consumer health products through the use of advanced analytical instruments such as ICP-MS, LC-MS/MS, GC-MS/MS, focused on trace level impurities accurate quantification to support regulatory submissions and contribute to the scientific understanding of the impurities.
Key Responsibilities
- Develop, validate, and transfer LC-MS/MS, GC-MS/MS, ICP-MS, etc methods for accurately quantifying impurities (e.g., elemental impurities, residual solvents, extractables & leachable, nitrosamines, etc.) at trace levels (ppm to sub-ppb) with MS for their risk assessment and mitigation strategies.
- Utilize mass spectrometry and other analytical instruments to solve complex structural and quantitative problems.
- Strong skills in method development, optimization, verification/validation and deep understanding of chemistry principles and formulation design aspects for test methods.
- Validate and transfer analytical methods to support product development and life cycle management projects.
- Conduct chemical extraction studies on container closure systems and consumer products to identify potential E&L, elemental impurities, residual solvents.
- Conduct method optimization, stability studies, and shelf-life assessments.
- Perform testing using HPLC/UPLC, GC, IC, AAS, and other advanced instrumentation.
- Manage method transfers to internal/external labs and manufacturing sites.
- Coordinate outsourcing of analytical operations and research projects when required.
- Author technical documents e.g., method development summary, method validation reports, method transfer, test methods, etc.
- Well experienced in a wide range of analytical technologies and instrumentation.
- Review and interpret analytical data against compliance to specifications and procedures and evaluate data trends.
- Author technical documents e.g., method development summary, method validation reports, method transfer, test methods, etc.
- Act as instrument owners for instrumentation and manage qualification and calibration activities and reports.
- Represent as process owners or subject matter experts for assigned responsibilities, critical laboratory processes, and quality systems.
- Participate in internal or regulatory audits as subject matter experts for assigned responsibilities.
- Stay current with industry trends and technologies to drive innovation.
- Independently manage analytical projects, including planning, execution, and stakeholder communication.
- Represent analytical requirements on cross-functional project teams and global forums.
- Participate in regional/global initiatives and share technical expertise.
- Drive innovation in analytical science and risk mitigation strategies.
- Collaborate across global teams to deliver high-quality outcomes.
What we are looking for
Required Qualifications
- Education: Minimum MSc, B Pharm, M. Pharm, Ph.D. or equivalent science stream
- Other Skills: MS office advanced
- Work experience: Minimum 7 years to 12 years in Analytical development, Quality Control, or related functions in healthcare/pharma/FMCG/Food/Nutraceuticals sector with exposure to GMP and Quality environment preferred.
- Strong hands-on expertise for identification, accurate quantification, and structural elucidation with hyphenated mass spectrometry techniques such as ICP-MS, LC-MS/MS, GC-MS/MS is must.
- Deep technical expertise related to chemistry, analytical techniques, method development, validation, stability, and research technologies. Solid understanding of analytical and physical testing capabilities.
- Capable of applying diversified expertise in technical principles and practices in broad chemistry areas or technology.
- Experience of handling software applications related to typical analytical technologies e.g., chromatographic systems, document control applications, electronic lab notebooks, etc.
- Adequate knowledge of current GMP, quality systems, SOPs, latest regulatory trends, and global regulations as appropriate
- Proven track record of successful Analytical projects. Experience working in Analytical Chemistry supporting new product development and life cycle management projects in a Consumer Health or Pharmaceutical environment.
- Strong knowledge in UPLC, HPLC, and GC, etc. to execute Analytical test method development, validation, and optimization.
- Excellent oral and written communication and articulation skills
- Flexible mindset adaptable to changing needs of business and organizational ways of working.
- Displays technical curiosity and self-initiative to deliver beyond usual activities.
- Good interpersonal skills to partner across functions, sites, and regions
- Fosters an innovative mindset and futuristic outlook.
What’s In It For You
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
Learning & Development Opportunities
Employee Resource Groups
This list could vary based on location/region
Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.
Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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