Johnson and Johnson Kenvue
Location
Mumbai | India
Job description
The objective of this position is to deliver analytical services to various Global RD sites for multiple product categories under various franchises such as Self Care (OTC drugs), Skin Health and Essential Health (Baby care, Oral Care, etc.) etc.
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 commercial products and specific research-based activities 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.
Key Responsibilities
ANALYSIS AND TECHNICAL ASSESSMENTS :
Responsible for method development and subsequent method validation activities including technical documentation.
Lead end to end method transfers process to labs and or manufacturing sites.
Plan, execute and manage stability testing for shelf-life assessment of stability studies.
Well qualified on wide range of analytical technologies and instrumentation.
Coordinate with external labs for outsourcing operations and research projects, if required.
ANALYTICAL DATA REVIEW AND INTERPRETATION :
Review and interpret analytical data against compliance to specifications and procedures and evaluate data trends
Evaluate analytical results and resolve any non-conformances and product related investigations including implementation of corrective action plans.
TECHNICAL DOCUMENT OWNERSHIP :
Author technical documents e.g. stability reports, method transfer and method validation protocol and reports, Global change control, product specifications, etc.
ACT AS PROCESS OWNERS:
Act as instrument owners for advanced 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.
PROJECT MANAGEMENT:
Independently manage analytical projects inclusive of planning, execution, communication with regional/global teams and presentations to stakeholders.
Represent cross functional project teams to share technical requirements, timelines, risk assessments, compliance needs related to specific analytical deliverables.
ENGAGEMENT ON REGIONAL/GLOBAL INITIATIVES:
Participate and collaborate with regional and Global teams for assigned deliverables when nominated on such forums.
Qualifications ÂWe Are Looking For
Required Qualifications
Deep technical expertise related to chemistry, analytical techniques, stability study assessment and research technologies.
Effective planning and execution of analytical projects independently with a right first-time approach.
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
Technical skills related to interpretation and review of analytical data, application of digital tools to area of work, resolution of laboratory investigations and non conformances through effective technical writing skills.
Ability to independently execute assigned work including technical troubleshooting acumen.
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.
Education: Minimum MSc, B Pharm, M. Pharm, Ph.D. or equivalent science stream
Other Skills: MS office advanced
Work experience: Minimum 7 years to 15 years in Analytical development, Quality Control or related functions in healthcare/pharma/FMCG sector with exposure to GMP and Quality environment preferred.
Job tags
Salary