Principal Scientist: Pharma Research Inhalation

Job Description

Design and development of drug combination products (inhalation and injectables) by understanding design space and managing critical design parameters.

· Lead and manage senior and junior device engineers

· Using design for manufacturing principles as well as geometric dimensioning and tolerance tools to create sound engineering drawings.

· Identify the best tools and approaches to effectively solve engineering problems.

· To develop, optimize and analyze designs by applying the appropriate mix of engineering principles, analytical, and experimental methods.

· Support the evaluation and assessment of new technologies, intellectual property, products, and processes

· Support current products in terms of quality, manufacturing, and cost improvement.

· Support execution of technical and cross-functional project work.

· Write detailed technical reports based on design verification testing for design changes and product design activities.

· Develop and implement detailed test methods

· Develop realistic and actionable design plans.

· Work across multiple device platforms such as inhalation, injectables, women’s healthcare and other drug device combination products

· Work with functions across various geographies and provide regular updates

· Ensure compliance with Lupin quality policies, standard operating procedures and practices

· Must have knowledge of and experience with Factory Acceptance Testing, Process Validation and IQ/OQ/PQ’s.

· Must demonstrate knowledge of US regulatory and quality requirements such as 21CFR820.30

Work Experience

 10 Years

Education

Competencies