Research Associate: Pharma Research-Inhalation (Pune_RD, MH, IN) bei Lupin

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

Competencies