Associate Scientist: Pharma Research-Inhalation

Lupin•Pune, MD

About The Position

Job Description Essential Duties and Responsibilities · Provide device and primary packaging expertise in a broader cross-functional drug product development organization, leading and coordinating the development and manufacturing of clinical and commercial device components and assembled devices in compliance with the Corporate, government and relevant industry standards, regulations and best practices. · Provide recommendations on strategies to select device material, developing device design concepts and incorporated technologies, cost-reduction, high-volume manufacturing and streamlining processes. · Leading the collaboration with internal and external development partners including monitoring work progress according to plan. · Monitor, support and challenge technical development as well as test and verification work. · Leading the definition of product requirements for medical devices and drug/device combination products. · Design, plan, perform, interpret, report results of studies related to development and related processes and procedures of medical devices with a focus on reliability testing, quality and documentation. · Develop efficient and robust devices and processes for the manufacture and/or analysis of Medical Devices/Combination Products, risk management activities, evaluating and challenging technical solutions. · Leading and monitoring documentation work and the development of a high-quality Design History Files (DHF). · Leading and monitoring human factors studies and activities. · Support Regulatory Affairs to prepare Medical Device/Combination Product pre-registration documents and provide input to answer Health Authority questions. Lead or support interaction with Health Authorities and various medical device industry governing and accreditation bodies. · Support/coach of team members, participation in project(s) sub-teams and contribution to overall strategies and goals. Education and Experience · Minimum: relevant degree in Engineering and at least 8 - 10 years of experience in a similar area with continuing education (EU) or BSc or equivalent. · Highly Desirable: Advanced degree in a scientific or relevant discipline (MSc or equivalent) and at least 5 years’ experience in medical device industry and pharmaceutical development experience. · Successfully demonstrated expertise in medical devices area. · Mechanical Engineering in general, especially experience in product design, injection molding of plastic components, testing and verification tools, equipment building and qualification desirable. Work Experience 8 - 10 years Education Masters in Medicinal Chemistry or Engineering Competencies

Requirements

relevant degree in Engineering and at least 8 - 10 years of experience in a similar area with continuing education (EU) or BSc or equivalent.
Successfully demonstrated expertise in medical devices area.
Work Experience 8 - 10 years
Education Masters in Medicinal Chemistry or Engineering

Nice To Haves

Advanced degree in a scientific or relevant discipline (MSc or equivalent) and at least 5 years’ experience in medical device industry and pharmaceutical development experience.
Mechanical Engineering in general, especially experience in product design, injection molding of plastic components, testing and verification tools, equipment building and qualification desirable.

Responsibilities

Provide device and primary packaging expertise in a broader cross-functional drug product development organization, leading and coordinating the development and manufacturing of clinical and commercial device components and assembled devices in compliance with the Corporate, government and relevant industry standards, regulations and best practices.
Provide recommendations on strategies to select device material, developing device design concepts and incorporated technologies, cost-reduction, high-volume manufacturing and streamlining processes.
Leading the collaboration with internal and external development partners including monitoring work progress according to plan.
Monitor, support and challenge technical development as well as test and verification work.
Leading the definition of product requirements for medical devices and drug/device combination products.
Design, plan, perform, interpret, report results of studies related to development and related processes and procedures of medical devices with a focus on reliability testing, quality and documentation.
Develop efficient and robust devices and processes for the manufacture and/or analysis of Medical Devices/Combination Products, risk management activities, evaluating and challenging technical solutions.
Leading and monitoring documentation work and the development of a high-quality Design History Files (DHF).
Leading and monitoring human factors studies and activities.
Support Regulatory Affairs to prepare Medical Device/Combination Product pre-registration documents and provide input to answer Health Authority questions. Lead or support interaction with Health Authorities and various medical device industry governing and accreditation bodies.
Support/coach of team members, participation in project(s) sub-teams and contribution to overall strategies and goals.